Method for aligning a stent graft delivery system

ABSTRACT

A method of implanting a prosthesis in a patient at a treatment site includes the steps of providing a prosthesis delivery sheath with an alignment device, loading a prosthesis into the sheath, advancing the sheath in a patient up to the treatment site, and viewing at least one of a rotational and an axial position of the alignment device at the treatment site and, if the sheath is not in a desired position, moving the sheath to the desired position based upon the position of the alignment device. The alignment device can be a pair of markers on opposing sides of a longitudinal axis of the sheath such that, when viewed from a side of the sheath, the pair forms a given shape that communicates to a user a direction in which the sheath needs to rotate minimally to align the markers and form the given shape.

CROSS-REFERENCE TO RELATED APPLICATION:

This application claims the benefit under 35 U.S.C. § 119(e) of U.S.Provisional Applications Nos. 60/833,533, filed Jul. 26, 2006 and60/765,449, filed Feb. 3, 2006, and is a divisional of co-pending U.S.patent application Ser. No. 10/844,136, filed Jul. 2, 2004, which is acontinuation in part of co-pending U.S. patent application Ser. No.10/784,462, filed Feb. 23, 2004, each of these co-pending applicationsclaiming the benefit under 35 U.S.C. § 119(e) of U.S. ProvisionalApplications Nos. 60/499,652, filed Sep. 3, 2003, and 60/500,155, filedSep. 4, 2003, the complete disclosures of these applications are allhereby incorporated by reference herein in their entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention lies in the field of endoluminal blood vessel repairs. Theinvention specifically relates to an alignment device for a stent graftdelivery system, a kit, and methods for endoluminally repairing avessel, for example, aneurysm and/or dissections of the thoracictransverse aortic arch, thoracic posterior aortic arch, and thedescending thoracic portion of the aorta with a stent graft.

2. Description of the Related Art

A stent graft is an implantable device made of a tube-shaped surgicalgraft covering and an expanding or self-expanding frame. The stent graftis placed inside a blood vessel to bridge, for example, an aneurismal,dissected, or other diseased segment of the blood vessel, and, thereby,exclude the hemodynamic pressures of blood flow from the diseasedsegment of the blood vessel.

In selected patients, a stent graft advantageously eliminates the needto perform open thoracic or abdominal surgical procedures to treatdiseases of the aorta and eliminates the need for total aorticreconstruction. Thus, the patient has less trauma and experiences adecrease in hospitalization and recovery times. The time needed toinsert a stent graft is substantially less than the typical anesthesiatime required for open aortic bypass surgical repair, for example.

Use of surgical and/or endovascular grafts have widespread usethroughout the world in vascular surgery. There are many different kindsof vascular graft configurations. Some have supporting framework overtheir entirety, some have only two stents as a supporting framework, andothers simply have the tube-shaped graft material with no additionalsupporting framework, an example that is not relevant to the presentinvention. One of the most commonly known supporting stent graftframeworks is that disclosed in U.S. Pat. Nos. 5,282,824 and 5,507,771to Gianturco (hereinafter collectively referred to as “Gianturco”).Gianturco describes a zig-zag-shaped, self-expanding stent commonlyreferred to as a z-stent. The stents are, preferably, made of nitinol,but also have been made from stainless steel and other biocompatiblematerials.

There are various features characterizing a stent graft. The firstsignificant feature is the tube of graft material. This tube is commonlyreferred to as the graft and forms the tubular shape that will,ultimately, take the place the diseased portion of the blood vessel. Thegraft is, preferably, made of a woven sheet (tube) of polyester or PTFE.The circumference of the graft tube is, typically, at least as large asthe diameter and/or circumference of the vessel into which the graftwill be inserted so that there is no possibility of blood flowing aroundthe graft (also referred to as endoleak) to either displace the graft orto reapply hemodynamic pressure against the diseased portion of theblood vessel. Accordingly, to so hold the graft, self-expandingframeworks are attached typically to the graft material, whether on theinterior or exterior thereof. Because blood flow within the lumen of thegraft could be impaired if the framework was disposed on the interiorwall of the graft, the framework is connected typically to the exteriorwall of the graft. The ridges formed by such an exterior framework helpto provide a better fit in the vessel by providing a sufficiently unevenouter surface that naturally grips the vessel where it contacts thevessel wall and also provides areas around which the vessel wall canendothelialize to further secure the stent graft in place.

One of the significant dangers in endovascular graft technology is thepossibility of the graft migrating from the desired position in which itis installed. Therefore, various devices have been created to assist inanchoring the graft to the vessel wall.

One type of prior art prosthetic device is a stent graft made of aself-expanding metallic framework. For delivery, the stent graft is,first, radially compressed and loaded into an introducer system thatwill deliver the device to the target area. When the introducer systemholding the stent graft positioned in an appropriate location in thevessel and allowed to open, the radial force imparted by theself-expanding framework is helpful, but, sometimes, not entirelysufficient, in endoluminally securing the stent graft within the vessel.

U.S. Pat. No. 5,824,041 to Lenker et al. (hereinafter “Lenker”)discloses an example of a stent graft delivery system. Lenker disclosesvarious embodiments in which a sheath is retractable proximally over aprosthesis to be released. With regard to FIGS. 7 and 8, Lenker namescomponents 72 and 76, respectively, as “sheath” and“prosthesis-containment sheath.” However, the latter is merely thecatheter in which the prosthesis 74 and the sheath 72 are held. Withregard to FIGS. 9 and 10, the sheath 82 has inner and outer layers 91,92 fluid-tightly connected to one another to form a ballooning structurearound the prosthesis P. This ballooning structure inflates when liquidis inflated with a non-compressible fluid medium and flares radiallyoutward when inflated. With regard to FIGS. 13 to 15, Lenker disclosesthe “sheath” 120, which is merely the delivery catheter, and aneversible membrane 126 that “folds back over itself (everts) as thesheath 120 is retracted so that there are always two layers of themembrane between the distal end of the sheath [120] and the prosthesisP.” Lenker at col. 9, lines 63 to 66. The eversion (peeling back) iscaused by direct connection of the distal end 130 to the sheath 120. TheLenker delivery system shown in FIGS. 19A to 19D holds the prosthesis Pat both ends 256, 258 while an outer catheter 254 is retracted over theprosthesis P and the inner sheath 260. The inner sheath 260 remainsinside the outer catheter 254 before, during, and after retraction.Another structure for holding the prosthesis P at both ends isillustrated in FIGS. 23A and 23B. Therein, the proximal holder havingresilient axial members 342 is connected to a proximal ring structure346. FIGS. 24A to 24C also show an embodiment for holding the prosthesisat both ends inside thin-walled tube 362.

To augment radial forces of stents, some prior art devices have addedproximal and/or distal stents that are not entirely covered by the graftmaterial. By not covering with graft material a portion of theproximal/distal ends of the stent, these stents have the ability toexpand further radially than those stents that are entirely covered bythe graft material. By expanding further, the proximal/distal stent endsbetter secure to the interior wall of the vessel and, in doing so, pressthe extreme cross-sectional surface of the graft ends into the vesselwall to create a fixated blood-tight seal.

One example of such a prior art exposed stent can be found in UnitedStates Patent Publication U.S. 2002/0198587 to Greenberg et al. Themodular stent graft assembly therein has a three-part stent graft: atwo-part graft having an aortic section 12 and an iliac section 14 (withfour sizes for each) and a contralateral iliac occluder 80. FIGS. 1, 2,and 4 to 6 show the attachment stent 32. As illustrated in FIGS. 1, 2,and 4, the attachment stent 32, while rounded, is relatively sharp and,therefore, increases the probability of puncturing the vessel.

A second example of a prior art exposed stent can be found in U.S.Patent Publication 2003/0074049 to Hoganson et al. (hereinafter“Hoganson”), which discloses a covered stent 10 in which the elongatedportions or sections 24 of the ends 20 a and 20 b extend beyond themarginal edges of the cover 22. See Hoganson at FIGS. 1, 3, 9, 11 a, 11b, 12 a, 12 b, and 13. However, these extending exposed edges aretriangular, with sharp apices pointing both upstream and downstream withregard to a graft placement location. Such a configuration of theexposed stent 20 a, 20 b increases the possibility of puncturing thevessel. In various embodiments shown in FIGS. 6 a, 6 b, 6 c, 10, 14 a,Hoganson teaches completely covering the extended stent and, therefore,the absence of a stent extending from the cover 22. It is noted that theHoganson stent is implanted by inflation of a balloon catheter.

Another example of a prior art exposed stent can be found in U.S. Pat.No. 6,565,596 to White et al. (hereinafter “White I”), which uses aproximally extending stent to prevent twisting or kinking and tomaintain graft against longitudinal movement. The extending stent isexpanded by a balloon and has a sinusoidal amplitude greater than thenext adjacent one or two sinusoidal wires. White I indicates that it isdesirable to space wires adjacent upstream end of graft as closetogether as is possible. The stent wires of White I are actually woveninto graft body by piercing the graft body at various locations. SeeWhite I at FIGS. 6 and 7. Thus, the rips in the graft body can lead tothe possibility of the exposed stent moving with respect to the graftand of the graft body ripping further. Between the portions of theextending stent 17, the graft body has apertures.

The stent configuration of U.S. Pat. No. 5,716,393 to Lindenberg et al.is similar to White I in that the outermost portion of the one-piecestent—made from a sheet that is cut/punched and then rolled intocylinder—has a front end with a greater amplitude than the remainingbody of the stent

A further example of a prior art exposed stent can be found in U.S. Pat.No. 6,524,335 to Hartley et al. (hereinafter “Hartley”). FIGS. 1 and 2of Hartley particularly disclose a proximal first stent 1 extendingproximally from graft proximal end 4 with both the proximal and distalapices narrowing to pointed ends.

Yet another example of a prior art exposed stent can be found in U.S.Pat. No. 6,355,056 to Pinheiro (hereinafter “Pinheiro I”). Like theHartley exposed stent, Pinheiro discloses exposed stents havingtriangular, sharp proximal apices.

Still a further example of a prior art exposed stent can be found inU.S. Pat. No. 6,099,558 to White et al. (hereinafter “White II”). TheWhite II exposed stent is similar to the exposed stent of White I andalso uses a balloon to expand the stent.

An added example of a prior art exposed stent can be found in U.S. Pat.No. 5,871,536 to Lazarus, which discloses two support members 68longitudinally extending from proximal end to a rounded point. Suchpoints, however, create a very significant possibility of piercing thevessel.

An additional example of a prior art exposed stent can be found in U.S.Pat. No. 5,851,228 to Pinheiro (hereinafter “Pinheiro II”). The PinheiroII exposed stents are similar to the exposed stents of Pinheiro I and,as such, have triangular, sharp, proximal apices.

Still another example of a prior art exposed stent can be found inLenker (U.S. Pat. No. 5,824,041), which shows a squared-off end of theproximal and distal exposed band members 14. A portion of the exposedmembers 14 that is attached to the graft material 18, 20 islongitudinally larger than a portion of the exposed members 14 that isexposed and extends away from the graft material 18, 20. Lenker et al.does not describe the members 14 in any detail.

Yet a further example of a prior art exposed stent can be found in U.S.Pat. No. 5,824,036 to Lauterjung, which, of all of the prior artembodiments described herein, shows the most pointed of exposed stents.Specifically, the proximal ends of the exposed stent are apices pointedlike a minaret. The minaret points are so shaped intentionally to allowforks 300 (see Lauterjung at FIG. 5) external to the stent 154 to pullthe stent 154 from the sheath 302, as opposed to being pushed.

A final example of a prior art exposed stent can be found in U.S. Pat.No. 5,755,778 to Kleshinski. The Kleshinski exposed stents each have twodifferent shaped portions, a triangular base portion and a looped endportion. The totality of each exposed cycle resembles a castellation.Even though the end-most portion of the stent is curved, because it isrelatively narrow, it still creates the possibility of piercing thevessel wall.

All of these prior art stents suffer from the disadvantageouscharacteristic that the relatively sharp proximal apices of the exposedstents have a shape that is likely to puncture the vessel wall.

Devices other than exposed stents have been used to inhibit graftmigration. A second of such devices is the placement of a relativelystiff longitudinal support member longitudinally extending along theentirety of the graft.

The typical stent graft has a tubular body and a circumferentialframework. This framework is not usually continuous. Rather, ittypically takes the form of a series of rings along the tubular graft.Some stent grafts have only one or two of such rings at the proximaland/or distal ends and some have many stents tandemly placed along theentirety of the graft material. Thus, the overall stent graft has an“accordion” shape. During the systolic phase of each cardiac cycle, thehemodynamic pressure within the vessel is substantially parallel withthe longitudinal plane of the stent graft. Therefore, a device havingunsecured stents, could behave like an accordion or concertina with eachsystolic pulsation, and may have a tendency to migrate downstream. (Adownstream migration, to achieve forward motion, has a repetitivelongitudinal compression and extension of its cylindrical body.) Suchmovement is entirely undesirable. Connecting the stents with supportalong the longitudinal extent of the device thereof can prevent suchmovement. To provide such support, a second anti-migration device can beembodied as a relatively stiff longitudinal bar connected to theframework.

A clear example of a longitudinal support bar can be found in Pinheiro I(6,355,056) and Pinheiro II (5,851,228). Each of these referencesdiscloses a plurality of longitudinally extending struts 40 extendingbetween and directly interconnecting the proximal and distal exposedstents 20 a, 20 b. These struts 40 are designed to extend generallyparallel with the inner lumen 15 of the graft 10, in other words, theyare straight.

Another example of a longitudinal support bar can be found in U.S. Pat.No. 6,464,719 to Jayaraman. The Jayaraman stent is formed from a grafttube 21 and a supporting sheet 1 made of nitinol. This sheet is bestshown in FIG. 3. The end pieces 11, 13 of the sheet are directlyconnected to one another by wavy longitudinal connecting pieces 15formed by cutting the sheet 1. To form the stent graft, the sheet 1 iscoiled with or around the cylindrical tube 21. See FIGS. 1 and 4.Alternatively, a plurality of connecting pieces 53 with holes at eachend thereof can be attached to a cylindrical fabric tube 51 by stitchingor sutures 57, as shown in FIG. 8. Jayaraman requires more than one ofthese serpentine shaped connecting pieces 53 to provide longitudinalsupport.

United States Patent Publication 2002/0016627 and U.S. Pat. No.6,312,458 to Golds each disclose a variation of a coiled securing member20.

A different kind of supporting member is disclosed in FIG. 8 of U.S.Pat. No. 6,053,943 to Edwin et al.

Like Jayaraman, U.S. Pat. No. 5,871,536 to Lazarus discloses a pluralityof straight, longitudinal support structures 38 attached to thecircumferential support structures 36, see FIGS. 1, 6, 7, 8, 10, 11, 12,14. FIG. 8 of Lazarus illustrates the longitudinal support structures 38attached to a distal structure 36 and extending almost all of the way tothe proximal structure 36. The longitudinal structures 38, 84, 94 can bedirectly connected to the body 22, 80 and can be telescopic 38, 64.

United States Patent Publication 2003/0088305 to Van Schie et al.(hereinafter “Van Schie”) does not disclose a support bar. Rather, itdiscloses a curved stent graft using an elastic material 8 connected tostents at a proximal end 2 and at a distal end 3 (see FIGS. 1, 2)thereof to create a curved stent graft. Because Van Schie needs tocreate a flexible curved graft, the elastic material 8 is made ofsilicone rubber or another similar material. Thus, the material 8 cannotprovide support in the longitudinal extent of the stent graft.Accordingly, an alternative to the elastic support material 8 is asuture material 25 shown in FIGS. 3 to 6.

SUMMARY OF THE INVENTION

The invention provides a method for aligning a stent graft deliverysystem and for repairing vessels with a stent graft that overcome thehereinafore-mentioned disadvantages of the heretofore-known devices andmethods of this general type and that provides a vessel repair devicethat implants/conforms more efficiently within the natural or diseasedcourse of the aorta by aligning with the natural curve of the aorta,decreases the likelihood of vessel puncture, increases the blood-tightvascular connection, retains the intraluminal wall of the vesselposition, is more resistant to migration, and delivers the stent graftinto a curved vessel while minimizing intraluminal forces impartedduring delivery and while minimizing the forces needed for a user todeliver the stent graft into a curved vessel.

With the foregoing and other objects in view, there is provided, inaccordance with the invention, a method of implanting a prosthesis in apatient at a treatment site, including the steps of providing aprosthesis delivery sheath with an alignment device, loading aprosthesis into the sheath, advancing the sheath in a patient up to thetreatment site, and viewing at least one of a rotational and an axialposition of the alignment device at the treatment site and, if thesheath is not in a desired position, moving the sheath to the desiredposition based upon the position of the alignment device. With theobjects of the invention in view, there is also provided a method ofimplanting a prosthesis in a patient at a treatment site, including thesteps of providing a prosthesis delivery sheath having an alignmentdevice, loading a prosthesis into the sheath, advancing the sheath in apatient up to the treatment site, and viewing the rotational position ofthe alignment device at the treatment site and, if the sheath is not ina rotationally desired position, rotating the sheath to the desiredposition. With the objects of the invention in view, there is alsoprovided a method of implanting a prosthesis in a patient at a treatmentsite, including the steps of providing a prosthesis delivery sheathhaving an alignment device, loading a prosthesis into the sheath,advancing the sheath in a patient up to the treatment site, and viewingthe axial position of the alignment device at the treatment site and, ifthe sheath is not in an axially desired position, one of extending andretracting the sheath to the desired axial position. With the objects ofthe invention in view, there is also provided a method of implanting aprosthesis in a patient at a treatment site, including the steps ofproviding a prosthesis delivery system with a relatively flexible innersheath and a relatively stiff outer sheath, providing the inner sheathwith an alignment device, loading a prosthesis inside the inner sheath,loading the inner sheath containing the prosthesis within the outersheath, and advancing the outer sheath in a patient towards thetreatment site up to a given position at a distance from the treatmentsite. While retaining the outer sheath in the given position, the innersheath is advanced out from the outer sheath to the treatment site. Theaxially position of the alignment device at the treatment site is viewedand, if the inner sheath is not in an axially desired position, theinner sheath is one of advanced and retracted to the desired position. Arotational position of the alignment device at the treatment site isviewed and, if the inner sheath is not in a rotationally desiredposition, the inner sheath is rotated to the desired position. The innersheath is retracted to at least partially implant the prosthesis at thetreatment site and, upon completion of prosthesis implantation, both ofthe inner and outer sheaths are retracted from the patient.

In accordance with another mode of the invention, the sheath isretracted to at least partially implant the prosthesis at the treatmentsite. In accordance with a further mode of the invention, the loadingstep is carried out by partially compressing the prosthesis in thesheath.

In accordance with an added mode of the invention, the prosthesisdelivery sheath is provided as an inner sheath, the inner sheath isslidably disposed in an outer sheath to further compress the prosthesiswhile the inner sheath is within the outer sheath, the outer sheathcontaining the inner sheath is advanced in a patient towards thetreatment site up to a given position at a distance from the treatmentsite, and, while retaining the outer sheath in the given position, theinner sheath is advanced out from the outer sheath to the treatment siteto permit expansion of the prosthesis to the partially compressed state.

In accordance with an additional mode of the invention, the inner sheathis retracted to at least partially implant the prosthesis at thetreatment site. In accordance with yet another mode of the invention,upon completion of prosthesis implantation, both of the inner and outersheaths are retracted from the patient. In accordance with yet a furthermode of the invention, the inner sheath is provided as a relativelyflexible inner sheath and the outer sheath as a relatively stiff outersheath. In accordance with yet an added mode of the invention, theadvancing step is carried out by advancing the outer sheath towards thetreatment site only up to a point at a distance from the treatment sitegreater than a longitudinal length of the prosthesis.

In accordance with yet an additional mode of the invention, theadvancing step is carried out by advancing the outer sheath invasculature of a patient towards a vascular treatment site, inparticular, in aortic vasculature of the patient no closer to the heartthan a celiac axis of the patient. In accordance with again another modeof the invention, the outer sheath is provided with a length sufficientto reach only up to a celiac axis of a patient. In accordance with againa further mode of the invention, the inner and outer sheath retractingsteps are carried out by retracting the inner sheath into the outersheath and subsequently retracting the outer sheath containing the innersheath from the patient. In accordance with again an added mode of theinvention, the inner sheath is provided with a prosthesis holding innerdiameter at least as great as an inner diameter of the outer sheath.

In accordance with again an additional mode of the invention, thealignment device is provided as a pair of radiopaque markers each havinga contact diameter and being symmetrical about the contact diameter onopposing sides of the contact diameter. The markers are connected atopposing sides of the sheath. In accordance with still another mode ofthe invention, the sheath is a tubular sheath having a proximate end andthe markers are placed at the proximate end on opposite sides thereof.In one embodiment, the markers are in a hemispherical shape and, inanother, the markers are each D-shaped. In accordance with still afurther mode of the invention, the markers are placed on opposite sidesof the sheath along respective longitudinal axes of the sheath,opposition of the markers forming a complete circular or ovular shapewhen the markers are viewed from an orientation aligning the axes withone another.

In accordance with still an added mode of the invention, the alignmentdevice is a pair of radiopaque markers each having a first shape andbeing connected to opposing sides of the sheath, each of the firstshapes including an alignment segment, and, in a plan view of one of themarkers, the alignment segments aligning with one another to, together,define a second shape different from the first shape. The second shapecan be symmetrical about the alignment segment. In accordance with stillan additional mode of the invention, the markers each have a shapeselected from a hemisphere, a D-shape, a triangle, and an isoscelestriangle. In accordance with another mode of the invention, thealignment device is a pair of symmetrically shaped and diametricallyopposed radiopaque markers connected to the sheath.

In accordance with a further mode of the invention, there are providedthe steps of providing the alignment device as a pair of radiopaquemarkers on opposing sides of a longitudinal axis of the sheath suchthat, when viewed from a side of the sheath, the markers together form agiven shape, carrying out the advancing step by advancing the sheath ina blood vessel while viewing the alignment device, and aligning thesheath in a given orientation by rotating the sheath along thelongitudinal axis until the viewed markers substantially form the givenshape, which can be any one of a circle, a diamond, and an oval.

In accordance with an additional mode of the invention, the markers areeach formed with a shape having a contact segment, the shape beingsymmetrical, when the two contact segments are aligned with one another,about the aligned contact segments. In accordance with yet another modeof the invention, each of the markers are shaped with an alignmentsegment and the alignment segments are aligned with one another to formthe given shape when viewed in a plan view of one of the markers. Inaccordance with yet a further mode of the invention, the given shape isselected to communicate to a user a direction in which the sheath needsto rotate minimally to align the markers in the given shape. Inaccordance with yet an added mode of the invention, the direction forminimal rotation is indicated with two flat diameters of the shape andtwo highest points of opposing curves of the shape.

In accordance with yet an additional mode of the invention, the axialposition of the alignment device is viewed at the treatment site and, ifthe sheath is not in an axially desired position, one of extending andretracting the sheath to the desired axial position. In accordance withagain another mode of the invention, the rotational position of thealignment device at the treatment site is viewed and, if the sheath isnot in a rotationally desired position, rotating the sheath to thedesired position.

In accordance with again a further mode of the invention, the alignmentdevice is provided as a pair of markers on opposing sides of alongitudinal axis of the sheath such that, when viewed from a side ofthe sheath, the pair of markers together form a given shape thatcommunicates to a user a direction in which the sheath needs to rotateminimally to align the markers and form the given shape, the advancingstep is carried out by advancing the sheath while viewing the alignmentdevice, and the sheath is aligned in a given orientation by rotating thesheath along the longitudinal axis until the viewed markerssubstantially form the given shape.

In accordance with again an added mode of the invention, the firstadvancing step is carried out by threading the inner and outer sheathsonto a guidewire and into a patient to place the outer sheath into anaorta of the patient only up to a point at a distance from the treatmentsite greater than a length of the prosthesis and the second advancingstep is carried out by advancing the inner sheath distally out of theouter catheter in the aorta towards the patient's heart to transport theprosthesis further upstream into the aorta.

In accordance with a concomitant mode of the invention, the advancingstep is carried out by advancing the inner sheath distally out of theouter sheath and into a curved thoracic aorta.

Other features that are considered as characteristic for the inventionare set forth in the appended claims. Although the invention isillustrated and described herein as embodied in a method for aligning astent graft delivery system and for repairing vessels with a stentgraft, it is, nevertheless, not intended to be limited to the detailsshown because various modifications and structural changes may be madetherein without departing from the spirit of the invention and withinthe scope and range of equivalents of the claims. The construction andmethod of operation of the invention, however, together with additionalobjects and advantages thereof, will be best understood from thefollowing description of specific embodiments when read in connectionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present invention, which are believed to be novel,are set forth with particularity in the appended claims. The invention,together with further objects and advantages thereof, may best beunderstood by reference to the following description, taken inconjunction with the accompanying drawings, in the several figures ofwhich like reference numerals identify like elements, and in which:

FIG. 1 is a side elevational view of a stent graft according to theinvention;

FIG. 2 is a side elevational view of a stent of the stent graft of FIG.1;

FIG. 3 is a cross-sectional view of the stent of FIG. 2 with differentembodiments of protrusions;

FIG. 4 is a perspective view of a prior art round mandrel for formingprior art stents;

FIG. 5 is a fragmentary, side elevational view of a prior art stent in aportion of a vessel;

FIG. 6 is a perspective view of a dodecahedral-shaped mandrel forforming stents in FIGS. 1 to 3;

FIG. 7 is a fragmentary, side elevational view of the stent of FIGS. 1to 3 in a portion of a vessel;

FIG. 8 is a fragmentary, enlarged side elevational view of the proximalend of the stent graft of FIG. 1 illustrating movement of a gimbaledend;

FIG. 9 is a side elevational view of a two-part stent graft according tothe invention;

FIG. 10 is a fragmentary, side elevational view of a delivery systemaccording to the invention with a locking ring in a neutral position;

FIG. 11 is a fragmentary, side elevational view of the delivery systemof FIG. 10 with the locking ring in an advancement position and, asindicated by dashed lines, a distal handle and sheath assembly in anadvanced position;

FIG. 12 is a fragmentary, enlarged view of a sheath assembly of thedelivery system of FIG. 10;

FIG. 13 is a fragmentary, enlarged view of an apex capture device of thedelivery system of FIG. 10 in a captured position;

FIG. 14 is a fragmentary, enlarged view of the apex capture device ofFIG. 13 in a released position;

FIG. 15 is a fragmentary, enlarged view of an apex release assembly ofthe delivery system of FIG. 10 in the captured position;

FIG. 16 is a fragmentary, enlarged view of the apex release assembly ofFIG. 15 in the captured position with an intermediate part removed;

FIG. 17 is a fragmentary, enlarged view of the apex release assembly ofFIG. 16 in the released position;

FIG. 18 is a fragmentary, side elevational view of the delivery systemof FIG. 11 showing how a user deploys the prosthesis;

FIG. 19 is a fragmentary cross-sectional view of human arteriesincluding the aorta with the assembly of the present invention in afirst step of a method for inserting the prosthesis according to theinvention;

FIG. 20 is a fragmentary cross-sectional view of the arteries of FIG. 19with the assembly in a subsequent step of the method for inserting theprosthesis;

FIG. 21 is a fragmentary cross-sectional view of the arteries of FIG. 20with the assembly in a subsequent step of the method for inserting theprosthesis;

FIG. 22 is a fragmentary cross-sectional view of the arteries of FIG. 21with the assembly in a subsequent step of the method for inserting theprosthesis;

FIG. 23 is a fragmentary cross-sectional view of the arteries of FIG. 22with the assembly in a subsequent step of the method for inserting theprosthesis;

FIG. 24 is a fragmentary cross-sectional view of the arteries of FIG. 23with the assembly in a subsequent step of the method for inserting theprosthesis;

FIG. 25 is a fragmentary, diagrammatic, perspective view of the coaxialrelationship of delivery system lumen according to the invention;

FIG. 26 is a fragmentary, cross-sectional view of the apex releaseassembly according to the invention;

FIG. 27 is a fragmentary, side elevational view of the stent graft ofFIG. 1 with various orientations of radiopaque markers according to theinvention;

FIG. 28 is a fragmentary perspective view of the stent graft of FIG. 1with various orientations of radiopaque markers according to theinvention;

FIG. 29 is a perspective view of a distal apex head of the apex capturedevice of FIG. 13;

FIG. 30 is a fragmentary side elevational view of the distal apex headof FIG. 29 and a proximal apex body of the apex capture device of FIG.13 with portions of a bare stent in the captured position;

FIG. 31 is a fragmentary, side elevational view of the distal apex headand proximal apex body of FIG. 30 with a portion of the proximal apexbody cut away to illustrate the bare stent in the captured position;

FIG. 32 is a fragmentary side elevational view of the distal apex headand proximal apex body of FIG. 30 in the released position;

FIG. 33 is a fragmentary, cross-sectional view of an embodiment ofhandle assemblies according to the invention;

FIG. 34 is a cross-sectional view of a pusher clasp rotator of thehandle assembly of FIG. 33;

FIG. 35 is a plan view of the pusher clasp rotator of FIG. 34 viewedalong line C-C;

FIG. 36 is a plan and partially hidden view of the pusher clasp rotatorof FIG. 34 with a helix groove for a first embodiment of the handleassembly of FIGS. 10, 11, and 18;

FIG. 37 is a cross-sectional view of the pusher clasp rotator of FIG. 36along section line A-A;

FIG. 38 is a plan and partially hidden view of the pusher clasp rotatorof FIG. 36;

FIG. 39 is a cross-sectional view of the pusher clasp rotator of FIG. 38along section line B-B;

FIG. 40 is a perspective view of a rotator body of the handle assemblyof FIG. 33;

FIG. 41 is an elevational and partially hidden side view of the rotatorbody of FIG. 40;

FIG. 42 is a cross-sectional view of the rotator body of FIG. 41 alongsection line A-A;

FIG. 43 is an elevational and partially hidden side view of the rotatorbody of FIG. 40;

FIG. 44 is an elevational and partially hidden side view of a pusherclasp body of the handle assembly of FIG. 33;

FIG. 45 is a cross-sectional view of the pusher clasp body of FIG. 44along section line A-A;

FIG. 46 is a cross-sectional view of the pusher clasp body of FIG. 44along section line B-B;

FIG. 47 is a fragmentary, side elevational view of a portion of thehandle assembly of FIG. 33 with a sheath assembly according to theinvention;

FIG. 48 is an exploded side elevational view of a portion of the handleassembly of FIG. 47;

FIG. 49 is a fragmentary elevational and partially hidden side view of ahandle body of the handle assembly of FIG. 33;

FIG. 50 is a fragmentary, exploded side elevational view of a portion ofa second embodiment of the handle assembly according to the invention;

FIG. 51 is a fragmentary, side elevational view of the portion of FIG.50 in a neutral position;

FIG. 52 is an exploded view of a first portion of the second embodimentof the handle assembly;

FIG. 53 is a fragmentary, exploded view of a larger portion of thesecond embodiment of the handle assembly as compared to FIG. 52 with thefirst portion and the sheath assembly;

FIG. 54 is perspective view of a clasp body of the second embodiment ofthe handle assembly;

FIG. 55 is an elevational side view of the clasp body of FIG. 54;

FIG. 56 is a cross-sectional view of the clasp body of FIG. 55 alongsection line A-A;

FIG. 57 is a plan view of the clasp body of FIG. 54;

FIG. 58 is a plan view of the clasp body of FIG. 57 viewed from sectionline B-B;

FIG. 59 is a fragmentary and partially hidden side elevational view of aclasp sleeve of the second embodiment of the handle assembly;

FIG. 60 is a fragmentary, cross-sectional view of a portion the claspsleeve of FIG. 59 along section line A;

FIG. 61 is a fragmentary, cross-sectional view of the clasp sleeve ofFIG. 59 along section line C-C;

FIG. 62 is a fragmentary and partially hidden side elevational view ofthe clasp sleeve of FIG. 59 rotated with respect to FIG. 59;

FIG. 63 is a fragmentary, cross-sectional view of the nose cone andsheath assemblies of FIG. 10;

FIG. 64 is a fragmentary, perspective view of a portion ofself-alignment configuration according to the invention;

FIG. 65 is a diagrammatic, fragmentary, cross-sectional view of a distalportion of the delivery system with the self-alignment configurationaccording to the invention inside the descending thoracic aorta and withthe self-alignment configuration in an orientation opposite a desiredorientation;

FIG. 66 is a diagrammatic, fragmentary, cross-sectional view of thedistal portion of the delivery system of FIG. 65 with the self-alignmentconfiguration partially inside the descending thoracic aorta andpartially inside the aortic arch and with the self-alignmentconfiguration in an crientation closer to the desired orientation;

FIG. 67 is a diagrammatic, fragmentary, cross-sectional view of thedistal portion of the delivery system of FIG. 65 with the self-alignmentconfiguration primarily inside the aortic arch and with theself-alignment configuration substantially in the desired orientation;

FIG. 68 is a fragmentary, enlarged, partially exploded perspective viewof an alternative embodiment of a distal end of the graft push lumen ofFIG. 25; and

FIG. 69 is a photograph of a user bending a stent graft assembly arounda curving device to impart a curve to a guidewire lumen therein.

DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

While the specification concludes with claims defining the features ofthe invention that are regarded as novel, it is believed that theinvention will be better understood from a consideration of thefollowing description in conjunction with the drawing figures, in whichlike reference numerals are carried forward.

The present invention provides an alignment device for a stent graft anddelivery system that treats, in particular, thoracic aortic defects fromthe brachiocephalic level of the aortic arch distally to a level justsuperior to the celiac axis and provides an endovascular foundation foran anastomosis with the thoracic aorta, while providing an alternativemethod for partial/total thoracic aortic repair by excluding the vesseldefect and making surgical repair of the aorta unnecessary. The stentgraft of the present invention, however, is not limited to use in theaorta.

It can be endoluminally inserted in any accessible artery that couldaccommodate the stent graft's dimensions.

Stent Graft: The stent graft according to the present invention providesvarious features that, heretofore, have not been applied in the art and,thereby, provide a vessel repair device that implants/conforms moreefficiently within the natural or diseased course of the aorta,decreases the likelihood of vessel puncture, and increases theblood-tight vascular connection, and decreases the probability of graftmobility.

The stent graft is implanted endovascularly before or during or in placeof an open repair of the vessel (i.e., an arch, in particular, theascending and/or descending portion of the aorta) through a deliverysystem described in detail below. The typical defects treated by thestent graft are aortic aneurysms, aortic dissections, and other diseasessuch as penetrating aortic ulcer, coarctation, and patent ductusarteriosus, related to the aorta. When endovascularly placed in theaorta, the stent graft forms a seal in the vessel and automaticallyaffixes itself to the vessel with resultant effacement of thepathological lesion.

Referring now to the figures of the drawings in detail and first,particularly to FIG. 1 thereof, there is shown an improved stent graft 1having a graft sleeve 10 and a number of stents 20. These stents 20 are,preferably, made of nitinol, an alloy having particularly specialproperties allowing it to rebound to a set configuration aftercompression, the rebounding property being based upon the temperature atwhich the alloy exists. For a detailed explanation of nitinol and itsapplication with regard to stents, see, e.g., U.S. Pat. Nos. 4,665,906,5,067,957, and 5,597,378 to Jervis and to Gianturco.

The graft sleeve 10 is cylindrical in shape and is made of a woven graftmaterial along its entire length. The graft material is, preferably,polyester, in particular, polyester referred to under the name DACRON®or other material types like Expanded Polytetrafluoroethylene (“EPTFE”),or other polymeric based coverings. The tubular graft sleeve 10 has aframework of individual lumen-supporting wires each referred to in theart as a stent 20. Connection of each stent 20 is, preferably, performedby sewing a polymeric (nylon, polyester) thread around an entirety ofthe stent 20 and through the graft sleeve 10. The stitch spacings aresufficiently close to prevent any edge of the stent 20 from extendingsubstantially further from the outer circumference of the graft sleeve10 than the diameter of the wire itself. Preferably, the stitches have a0.5 mm to 5 mm spacing.

The stents 20 are sewn either to the exterior or interior surfaces ofthe graft sleeve 10. FIG. 1 illustrates all stents 20, 30 on theexterior surface 16 of the graft sleeve 10. In a preferrednon-illustrated embodiment, the most proximal 23 and distal stents and abare stent 30 are connected to the interior surface of the graft sleeve10 and the remainder of the stents 20 are connected to the exteriorsurface 16. Another possible non-illustrated embodiment alternatesconnection of the stents 20, 30 to the graft sleeve 10 from the graftexterior surface to the graft interior surface, the alternation havingany periodic sequence.

A stent 20, when connected to the graft sleeve 10, radially forces thegraft sleeve 10 open to a predetermined diameter D. The released radialforce creates a seal with the vessel wall and affixes the graft to thevessel wall when the graft is implanted in the vessel and is allowed toexpand.

Typically, the stents 20 are sized to fully expand to the diameter D ofthe fully expanded graft sleeve 10. However, a characteristic of thepresent invention is that each of the stents 20 and 30 has a diameterlarger than the diameter D of the fully expanded graft sleeve 10. Thus,when the stent graft 1 is fully expanded and resting on the internalsurface of the vessel where it has been placed, each stent 20 isimparting independently a radially directed force to the graft sleeve10. Such pre-compression, as it is referred to herein, is applied (1) toensure that the graft covering is fully extended, (2) to ensuresufficient stent radial force to make sure sealing occurs, (3) to affixthe stent graft and prevent it from kinking, and (4) to affix the stentgraft and prevent migration.

Preferably, each of the stents 20 is formed with a single nitinol wire.Of course other biocompatible materials can be used, for example,stainless steel, biopolymers, cobalt chrome, and titanium alloys.

The preferred shape of each stent 20 corresponds to what is referred inthe art as a Z-stent, see, e.g., Gianturco (although the shape of thestents 20 can be in any form that satisfies the functions of aself-expanding stent). Thus, the wire forming the stent 20 is a ringhaving a wavy or sinusoidal shape. In particular, an elevational vieworthogonal to the center axis 21 of the stent 20 reveals a shapesomewhere between a triangular wave and a sinusoidal wave as shown inFIG. 2. In other words, the view of FIG. 2 shows that the stents 20 eachhave alternating proximal 22 and distal 24 apices. Preferably, theapices have a radius r that does not present too great of a pointtowards a vessel wall to prevent any possibility of puncturing thevessel, regardless of the complete circumferential connection to thegraft sleeve 10. In particular, the radius r of curvature of theproximal 22 and distal 24 apices of the stent 20 are, preferably, equal.The radius of curvature r is between approximately 0.1 mm andapproximately 3.0 mm, in particular, approximately 0.5 mm.

Another advantageous feature of a stent lies in extending thelongitudinal profile along which the stent contacts the inner wall of avessel. This longitudinal profile can be explained with reference toFIGS. 3 to 7.

Prior art stents and stents according to the present invention areformed on mandrels 29, 29′ by winding the wire around the mandrel 29,29′ and forming the apexes 22, 24, 32, 34 by wrapping the wire overnon-illustrated pins that protrude perpendicular from the axis of themandrel. Such pins, if illustrated, would be located in the holesillustrated in the mandrels 29, 29′ of FIGS. 4 and 6. Prior art stentsare formed on a round mandrel 29 (also referred to as a bar). A stent20′ formed on a round mandrel 29 has a profile that is rounded (see FIG.5). Because of the rounded profile, the stent 20′ does not conformevenly against the inner wall of the vessel 2 in which it is inserted.This disadvantage is critical in the area of stent graft 1 sealzones—areas where the ends of the graft 10 need to be laid against theinner wall of the vessel 2. Clinical experience reveals that stents 20′formed with the round mandrel 29 do not lie against the vessel 2;instead, only a mid-section of the stent 20′ rests against the vessel 2,as shown in FIG. 5. Accordingly, when such a stent 20′ is present ateither of the proximal 12 or distal 14 ends of the stent graft 1, thegraft material flares away from the wall of the vessel 2 into thelumen—a condition that is to be avoided. An example of this flaring canbe seen by comparing the upper and lower portions of the curvedlongitudinal profile of the stent 20′ in FIG. 5 with the linearlongitudinal profile of the vessel 2.

To remedy this problem and ensure co-columnar apposition of the stentand vessel, stents 20 of the present invention are formed on amultiple-sided mandrel. In particular, the stents 20 are formed on apolygonal-shaped mandrel 29′. The mandrel 29′ does not have sharp edges.Instead, it has flat sections and rounded edge portions between therespective flat sections. Thus, a stent formed on the mandrel 29′ willhave a cross-section that is somewhat round but polygonal, as shown inFIG. 3. The cross-sectional view orthogonal to the center axis 21 ofsuch a stent 20 will have beveled or rounded edges 31 (corresponding tothe rounded edge portions of the mandrel 29′) disposed between flatsides or struts 33 (corresponding to the flat sections of the mandrel29′).

To manufacture the stent 20, apexes of the stents 20 are formed bywinding the wire over non-illustrated pins located on the roundedportions of the mandrel 29′. Thus, the struts 33 lying between theapexes 22, 24, 32, 34 of the stents 20 lie flat against the flat sidesof the mandrel 29′. When so formed on the inventive mandrel 29′, thelongitudinal profile is substantially less rounded than the profile ofstent 20′ and, in practice, is substantially linear.

For stents 20 having six proximal 22 and six distal 24 apices, thestents 20 are formed on a dodecahedron-shaped mandrel 29′ (a mandrelhaving twelve sides), which mandrel 29′ is shown in FIG. 6. A stent 20formed on such a mandrel 29′ will have the cross-section illustrated inFIG. 3.

The fourteen-apex stent 20 shown in FIG. 7 illustrates a stent 20 thathas been formed on a fourteen-sided mandrel. The stent 20 in FIG. 7 ispolygonal in cross-section (having fourteen sides) and, as shown in FIG.7, has a substantially linear longitudinal profile. Clinically, thelinear longitudinal profile improves the stent's 20 ability to conformto the vessel 2 and press the graft sleeve 10 outward in the sealingzones at the extremities of the individual stent 20.

Another way to improve the performance of the stent graft 1 is toprovide the distal-most stent 25 on the graft 10 (i.e., downstream) withadditional apices and to give it a longer longitudinal length (i.e.,greater amplitude) and/or a longer circumferential length. When a stent25 having a longer circumferential length is sewn to a graft, the stentgraft 1 will perform better clinically. The improvement, in part, is dueto a need for the distal portion of the graft material 10 to be pressedfirmly against the wall of the vessel. The additional apices result inadditional points of contact between the stent graft 1 and vessel wall,thus ensuring better apposition to the wall of the vessel and bettersealing of the graft material 10 to the vessel. The increased appositionand sealing substantially improves the axial alignment of the distal end14 of the stent graft 1 to the vessel. As set forth above, each of thestents 20 and 30 has a diameter larger than the diameter D of the fullyexpanded graft sleeve 10. Thus, if the distal stent 25 also has adiameter larger than the diameter D, it will impart a greater radialbias on all 360 degrees of the corresponding section of the graft thanstents not having such an oversized configuration.

A typical implanted stent graft 1 typically does not experience alifting off at straight portions of a vessel because the radial bias ofthe stents acting upon the graft sleeve give adequate pressure to alignthe stent and graft sleeve with the vessel wall. However, when a typicalstent graft is implanted in a curved vessel (such as the aorta), thedistal end of the stent graft 1 does experience a lift off from thevessel wall. The increased apposition and sealing of the stent graft Iaccording to the present invention substantially decreases theprobability of lift off because the added height and additional apicesenhance the alignment of the stent graft perpendicular to the vesselwall as compared to prior art stent grafts (no lift off occurs).

The number of total apices of a stent is dependent upon the diameter ofthe vessel in which the stent graft 1 is to be implanted. Vessels havinga smaller diameter have a smaller total number of apices than a stent tobe implanted in a vessel having a larger diameter. Table 1 belowindicates preferred stent embodiments for vessels having differentdiameters. For example, if a vessel has a 26 or 27 mm diameter, then apreferred diameter of the graft sleeve 10 is 30 mm. For a 30 mm diametergraft sleeve, the intermediate stents 20 will have 5 apices on each side(proximal and distal) for a total of 10 apices. In other words, thestent defines 5 periodic “waves.” The distal-most stent 25, incomparison, defines 6 periodic “waves” and, therefore, has 12 totalapices. It is noted that the distal-most stent 25 in FIG. 1 does nothave the additional apex. While Table 1 indicates preferred embodiments,these configurations can be adjusted or changed as needed. TABLE 1 StentApices/Side Vessel Diameter (mm) Graft Diameter (mm) (Distal-most Stent#) 19 22 5 (5) 20-21 24 5 (5) 22-23 26 5 (5) 24-25 28 5 (6) 26-27 30 5(6) 28-29 32 6 (7) 30-31 34 6 (7) 32-33 36 6 (7) 34 38 6 (7) 35-36 40 7(8) 37-38 42 7 (8) 39-40 44 7 (8) 41-42 46 7 (8)

To increase the security of the stent graft 1 in a vessel, an exposed orbare stent 30 is provided on the stent graft 1, preferably, only at theproximal end 12 of the graft sleeve 10—proximal meaning that it isattached to the portion of the graft sleeve 10 from which the bloodflows into the sleeve, i.e., blood flows from the bare stent 30 andthrough the sleeve 10 to the left 10 of FIG. 1. The bare stent 30 is notlimited to being attached at the proximal end 12. Anothernon-illustrated bare stent can be attached similarly to the distal end14 of the graft sleeve 10.

Significantly, the bare stent 30 is only partially attached to the graftsleeve 10. Specifically, the bare stent 30 is fixed to the graft sleeve10 only at the distal apices 34 of the bare stent 30. Thus, the barestent 30 is partially free to extend the proximal apices 32 away 15 fromthe proximal end of the graft sleeve 10.

The bare stent 30 has various properties, the primary one being toimprove the apposition of the graft material to the contour of thevessel wall and to align the proximal portion of the graft covering inthe lumen of the arch and provide a blood-tight closure of the proximalend 12 of the graft sleeve 10 so that blood does not pass between thevascular inside wall and outer surface 16 of the sleeve 10 (endoleak).

The preferred configuration for the radius of curvature α of the distalapices 34 is substantially equal to the radius r of the proximal 22 anddistal 24 apices of the stent 20, in particular, it is equal at least tothe radius of curvature r of the proximal apices of the stent 20directly adjacent the bare stent 30. Thus, as shown in FIG. 8, adistance between the proximal apices 22 of the most proximal stent 23and crossing points of the exposed portions of the bare stent 30 aresubstantially at a same distance from one another all the way around thecircumference of the proximal end 12 of the graft sleeve 10. Preferably,this distance varies based upon the graft diameter. Accordingly, thesinusoidal portion of the distal apices 34 connected to the graft sleeve10 traverse substantially the same path as that of the stent 23 closestto the bare stent 30. Thus, the distance d between the stent 22 and allportions of the bare stent 30 connected to the graft sleeve 10 remainconstant. Such a configuration is advantageous because it maintains thesymmetry of radial force of the device about the circumference of thevessel and also aids in the synchronous, simultaneous expansion of thedevice, thus increasing apposition of the graft material to the vesselwall to induce a proximal seal—and substantially improve the proximalseal—due to increasing outward force members in contact with the vesselwall.

Inter-positioning the stents 23, 30 in phase with one another, createsan overlap, i.e., the apices 34 of the bare stent 30 are positionedwithin the troughs of the stent 23. A further advantage of such aconfiguration is that the overlap provides twice as many points ofcontact between the proximal opening of the graft 10 and the vessel inwhich the stent graft 1 is implanted. The additional apposition pointskeep the proximal opening of the graft sleeve 10 open against the vesselwall, which substantially reduces the potential for endoleaks. Inaddition, the overlap of the stents 23, 30 increases the radial load orresistance to compression, which functionally increases fixation andreduces the potential for device migration.

In contrast to the distal apices 34 of the bare stent 30, the radius ofcurvature β of the proximal apices 32 (those apices that are not sewninto the graft sleeve 10) is significantly larger than the radius ofcurvature α of the distal apices 34. A preferred configuration for thebare stent apices has a radius approximately equal to 1.5 mm for theproximal apices 32 and approximately equal to 0.5 mm for the distalapices 34. Such a configuration substantially prevents perforation ofthe blood vessel by the proximal apices 32, or, at a minimum, makes ismuch less likely for the bare stent 30 to perforate the vessel becauseof the less-sharp curvature of the proximal apices 32.

The bare stent 30 also has an amplitude greater than the other stents20. Preferably, the peak-to-peak amplitude of the stents 20 isapproximately 1.3 cm to 1.5 cm, whereas the peak-to-peak amplitude ofthe bare stent 30 is approximately 2.5 cm to 4.0 cm. Accordingly, theforce exerted by the bare stent 30 on the inner wall of the aorta (dueto the bare stent 30 expanding to its native position) is spread over alarger surface area. Thus, the bare stent 30 of the present inventionpresents a less traumatic radial stress to the interior of the vesselwall—a characteristic that, while less per square mm than an individualone of the stents 20 would be, is sufficient, nonetheless, to retain theproximal end 12 in position. Simultaneously, the taller configuration ofthe bare stent 30 guides the proximal opening of the stent graft in amore “squared-off” manner. Thus, the proximal opening of the stent graftis more aligned with the natural curvature of the vessel in the area ofthe proximal opening.

As set forth above, because the vessel moves constantly, and due to theconstantly changing pressure imparted by blood flow, any stent graftplaced in the vessel has the natural tendency to migrate downstream.This is especially true when the stent graft 1 has graft sleeve segments18 with lengths defined by the separation of the stents on either end ofthe segment 18, giving the stent graft 1 an accordion, concertina, orcaterpillar-like shape. When such a shape is pulsating with the vesseland while hemodynamic pressure is imparted in a pulsating manner alongthe stent graft from the proximal end 12 to the downstream distal end14, the stent graft 1 has a tendency to migrate downstream in thevessel. It is desired to have such motion be entirely prohibited.

Support along a longitudinal extent of the graft sleeve 10 assists inpreventing such movement. Accordingly, as set forth above, prior artstent grafts have provided longitudinal rods extending in a straightline from one stent to another.

The present invention, however, provides a longitudinal,spiraling/helical support member 40 that, while extending relativelyparallel to the longitudinal axis 11 of the graft sleeve 10, is notaligned substantially parallel to a longitudinal extent of the entiretyof the stent graft 1 as done in the prior art. “Relatively parallel” isreferred to herein as an extent that is more along the longitudinal axis11 of the stent graft 1 than along an axis perpendicular thereto.

Specifically, the longitudinal support member 40 has a somewhat S-turnshape, in that, a proximal portion 42 is relatively parallel to the axis11 of the graft sleeve 10 at a first degree 41 (being defined as adegree of the 360 degrees of the circumference of the graft sleeve 10),and a distal portion 44 is, also, relatively parallel to the axis 11 ofthe tube graft, but at a different second degree 43 on the circumferenceof the graft sleeve 10. The difference between the first and seconddegrees 41, 43 is dependent upon the length L of the graft sleeve 10.For an approximately 20 cm (approx. 8″) graft sleeve, for example, thesecond degree 43 is between 80 and 110 degrees away from the firstdegree 41, in particular, approximately 90 degrees away. In comparison,for an approximately 9 cm (approx. 3.5″) graft sleeve, the second degree43 is between 30 and 60 degrees away from the first degree 41, inparticular, approximately 45 degrees away. As set forth below, thedistance between the first and second degrees 41, 43 is also dependentupon the curvature and the kind of curvature that the stent graft 1 willbe exposed to when in vivo.

The longitudinal support member 40 has a curved intermediate portion 46between the proximal and distal portions 42, 44. By using the word“portion” it is not intended to mean that the rod is in three separateparts (of course, in a particular configuration, a multi-part embodimentis possible). A preferred embodiment of the longitudinal support member40 is a single, one-piece rod made of stainless steel, cobalt chrome,nitinol, or polymeric material that is shaped as a fully curved helix42, 44, 46 without any straight portion. In an alternative stent graftembodiment, the proximal and distal portions 42, 44 can be substantiallyparallel to the axis 11 of the stent graft 1 and the central portion 46can be helically curved.

One way to describe the preferred curvature embodiment of thelongitudinal support member 40 can be using an analogy of asymptotes. Ifthere are two asymptotes extending parallel to the longitudinal axis 11of the graft sleeve 10 at the first and second degrees 41, 43 on thegraft sleeve 10, then the proximal portion 42 can be on the first degree41 or extend approximately asymptotically to the first degree 41 and thedistal portion 44 can be on the second degree 43 or extend approximatelyasymptotically to the second degree 43. Because the longitudinal supportmember 40 is one piece in a preferred embodiment, the curved portion 46follows the natural curve formed by placing the proximal and distalportions 42, 44 as set forth herein.

In such a position, the curved longitudinal support member 40 has acenterline 45 (parallel to the longitudinal axis 11 of the graft sleeve10 halfway between the first and second degrees 41, 43 on the graftsleeve 10). In this embodiment, therefore, the curved portion intersectsthe centerline 45 at approximately 20 to 40 degrees in magnitude,preferably at approximately 30 to 35 degrees.

Another way to describe the curvature of the longitudinal support membercan be with respect to the centerline 45. The portion of thelongitudinal support member 40 between the first degree 41 and thecenterline 45 is approximately a mirror image of the portion of thelongitudinal support member 40 between the second degree 43 and thecenterline 45, but rotated one-hundred eighty degrees (180°) around anaxis orthogonal to the centerline 45. Such symmetry can be referred toherein as “reverse-mirror symmetrical.”

The longitudinal support member 40 is, preferably, sewn to the graftsleeve 10 in the same way as the stents 20. However, the longitudinalsupport member 40 is not sewn directly to any of the stents 20 in theproximal portions of the graft. In other words, the longitudinal supportmember 40 is independent of the proximal skeleton formed by the stents20. Such a configuration is advantageous because an independent proximalend creates a gimbal that endows the stent graft with additionalflexibility. Specifically, the gimbaled proximal end allows the proximalend to align better to the proximal point of apposition, thus reducingthe chance for endoleak. The additional independence from thelongitudinal support member allows the proximal fixation point to beindependent from the distal section that is undergoing related motiondue to the physiological motion of pulsutile flow of blood. Also in apreferred embodiment, the longitudinal support member 40 is pre-formedin the desired spiral/helical shape (counter-clockwise from proximal todistal), before being attached to the graft sleeve 10.

Because vessels receiving the stent graft 1 are not typically straight(especially the aortic arch), the final implanted position of the stentgraft 1 will, most likely, be curved in some way. In prior art stentgrafts (which only provide longitudinally parallel support rods), thereexist, inherently, a force that urges the rod, and, thereby, the entirestent graft, to the straightened, natural shape of the rod. This forceis disadvantageous for stent grafts that are to be installed in an atleast partly curved manner.

The curved shape of the longitudinal support member 40 according to thepresent invention eliminates at least a majority, or substantially all,of this disadvantage because the longitudinal support member's 40natural shape is curved. Therefore, the support member 40 imparts lessof a force, or none at all, to straighten the longitudinal supportmember 40, and, thereby, move the implanted stent graft in anundesirable way. At the same time, the curved longitudinal supportmember 40 negates the effect of the latent kinetic force residing in theaortic wall that is generated by the propagation of the pulse wave andsystolic blood pressure in the cardiac cycle, which is, then, releasedduring diastole. As set forth in more detail below, the delivery systemof the present invention automatically aligns the stent graft 1 to themost optimal position while traversing the curved vessel in which it isto be implanted, specifically, the longitudinal support member 40 isplaced substantially at the superior longitudinal surface line of thecurved aorta (with respect to anatomical position).

In a preferred embodiment, the longitudinal support member 40 can becurved in a patient-customized way to accommodate the anticipated curveof the actual vessel in which the graft will be implanted. Thus, thedistance between the first and second degrees 41, 43 will be dependentupon the curvature and the kind of curvature that the stent graft 1 willbe exposed to when in vivo. As such, when implanted, the curvedlongitudinal support member 40 will, actually, exhibit an opposite forceagainst any environment that would alter its conformance to the shape ofits resident vessel's existing course(es).

Preferably, the support member 40 is sewn, in a similar manner as thestents 20, on the outside surface 16 of the graft sleeve 10.

In prior art support rods, the ends thereof are merely a terminating endof a steel or nitinol rod and are, therefore, sharp. Even though theseends are sewn to the tube graft in the prior art, the possibility oftearing the vessel wall still exists. It is, therefore, desirable to notprovide the support rod with sharp ends that could puncture the vesselin which the stent graft is placed.

The two ends of the longitudinal support member 40 of the presentinvention do not end abruptly. Instead, each end of the longitudinalsupport member loops 47 back upon itself such that the end of thelongitudinal support member along the axis of the stent graft is notsharp and, instead, presents an exterior of a circular or oval shapewhen viewed from the ends 12, 14 of the graft sleeve 10. Such aconfiguration substantially prevents the possibility of tearing thevessel wall and also provides additional longitudinal support at theoval shape by having two longitudinally extending sides of the oval 47.

In addition, in another embodiment, the end of the longitudinal supportmember may be connected to the second proximal stent 28 and to the mostdistal stent. This configuration would allow the longitudinal supportmember to be affixed to stent 28 (see FIG. 1) and the most distal stentfor support while still allowing for the gimbaled feature of theproximal end of the stent graft to be maintained.

A significant feature of the longitudinal support member 40 is that theends of the longitudinal support member 40 may not extend all the way tothe two ends 12, 14 of the graft sleeve 10. Instead, the longitudinalsupport member 40 terminates at or prior to the second-to-last stent 28at the proximal end 12, and, if desired, prior to the second-to-laststent 28′ at the distal end 14 of the graft sleeve 10. Such an endingconfiguration (whether proximal only or both proximal and distal) ischosen for a particular reason—when the longitudinal support member 40ends before either of the planes defined by cross-sectional lines 52,52′, the sleeve 10 and the stents 20 connected thereto respectively formgimbaled portions 50, 50′. In other words, when a grasping force actingupon the gimbaled ends 50, 50′ moves or pivots the cross-sectional planedefining each end opening of the graft sleeve 10 about the longitudinalaxis 11 starting from the planes defined by the cross-sectional lines52, 52′, then the moving portions 50, 50′ can be oriented at any angle γabout the center of the circular opening in all directions (360degrees), as shown in FIG. 8. The natural gimbal, thus, allows the ends50, 50′ to be inclined in any radial direction away from thelongitudinal axis 11.

Among other things, the gimbaled ends 50, 50′ allow each end opening todynamically align naturally to the curve of the vessel in which it isimplanted. A significant advantage of the gimbaled ends 50, 50′ is thatthey limit propagation of the forces acting upon the separate parts.Specifically, a force that, previously, would act upon the entirety ofthe stent graft 1, in other words, both the end portions 50, 50′ and themiddle portion of the stent graft 1 (i.e., between planes 52, 52′), nowprincipally acts upon the portion in which the force occurs. Forexample, a force that acts only upon one of the end portions 50, 50′substantially does not propagate into the middle portion of the stentgraft 1 (i.e., between planes 52, 52′). More significantly, however,when a force acts upon the middle portion of the stent graft 1 (whethermoving longitudinally, axially (dilation), or in a torqued manner), theends 50, 50′, because they are gimbaled, remain relatively completelyaligned with the natural contours of the vessel surrounding therespective end 50, 50′ and have virtually none of the force transferredthereto, which force could potentially cause the ends to grate, rub, orshift from their desired fixed position in the vessel. Accordingly, thestent graft ends 50, 50′ remain fixed in the implanted position andextend the seating life of the stent graft 1.

Another advantage of the longitudinal support member 40 is that itincreases the columnar strength of the graft stent 1. Specifically, thematerial of the graft sleeve can be compressed easily along thelongitudinal axis 11, a property that remains true even with thepresence of the stents 20 so long as the stents 20 are attached to thegraft sleeve 10 with a spacing between the distal apices 24 of one stent20 and the proximal apices 22 of the next adjacent stent 20. This isespecially true for the amount of force imparted by the flow of bloodalong the extent of the longitudinal axis 11. However, with thelongitudinal support member 40 attached according to the presentinvention, longitudinal strength of the stent graft 1 increases toovercome the longitudinal forces imparted by blood flow.

Another benefit imparted by having such increased longitudinal strengthis that the stent graft 1 is further prevented from migrating in thevessel because the tube graft is not compressing and expanding in anaccordion-like manner—movement that would, inherently, cause graftmigration.

A further measure for preventing migration of the stent graft 1 is toequip at least one of any of the individual stents 20, 30 or thelongitudinal support member 40 with protuberances 60, such as barbs orhooks (FIG. 3). See, e.g., United States Patent Publication 2002/0052660to Greenhalgh. In the preferred embodiment of the present invention, thestents 20, 30 are secured to the outer circumferential surface 16 of thegraft sleeve 10. Accordingly, if the stents 20 (or connected portions ofstent 30) have protuberances 60 protruding outwardly, then such featureswould catch the interior wall of the vessel and add to the prevention ofstent graft 1 migration. Such an embodiment can be preferred foraneurysms but is not preferred for the fragile characteristics ofdissections because such protuberances 60 can excoriate the innerlayer(s) of the vessel and cause leaks between layers, for example.

As shown in FIG. 9, the stent graft 1 is not limited to a single graftsleeve 10. Instead, the entire stent graft can be a first stent graft100 having all of the features of the stent graft 1 described above anda second stent graft 200 that, instead of having a circular extremeproximal end 12, as set forth above, has a proximal end 212 with a shapefollowing the contour of the most proximal stent 220 and is slightlylarger in circumference than the distal circumference of the first stentgraft 100. Therefore, an insertion of the proximal end 212 of the secondstent graft 200 into the distal end 114 of the first stent graft 100results, in total, in a two-part stent graft. Because blood flows fromthe proximal end 112 of the first stent graft 100 to the distal end 214of the second stent graft 200, it is preferable to have the first stentgraft 100 fit inside the second stent graft 200 to prevent blood fromleaking out therebetween. This configuration can be achieved byimplanting the devices in reverse order (first implant graft 200 and,then, implant graft 100. Each of the stent grafts 100, 200 can have itsown longitudinal support member 40 as needed.

It is not significant if the stent apices of the distal-most stent ofthe first stent graft 100 are not aligned with the stent apices of theproximal-most stent 220 of the second stent graft 200. What is importantis the amount of junctional overlap between the two grafts 100, 200.

Delivery System

As set forth above, the prior art includes many different systems forendoluminally delivering a prosthesis, in particular, a stent graft, toa vessel. Many of the delivery systems have similar parts and most areguided along a guidewire that is inserted, typically, through aninsertion into the femoral artery near a patient's groin prior to use ofthe delivery system. To prevent puncture of the arteries leading to andincluding the aorta, the delivery system is coaxially connected to theguidewire and tracks the course of the guidewire up to the aorta. Theparts of the delivery system that will track over the wire are,therefore, sized to have an outside diameter smaller than the insidediameter of the femoral artery of the patient. The delivery systemcomponents that track over the guidewire include the stent graft and aremade of a series of coaxial lumens referred to as catheters and sheaths.The stent graft is constrained, typically, by an outer catheter,requiring the stent graft to be compressed to fit inside the outercatheter. Doing so makes the portion of the delivery system thatconstrains the stent graft very stiff, which, therefore, reduces thatportion's flexibility and makes it difficult for the delivery system totrack over the guidewire, especially along curved vessels such as theaortic arch. In addition, because the stent graft exerts very highradial forces on the constraining catheter due to the amount that itmust be compressed to fit inside the catheter, the process of deployingthe stent graft by sliding the constraining catheter off of the stentgraft requires a very high amount of force, typically referred to as adeployment force. Also, the catheter has to be strong enough toconstrain the graft, requiring it to be made of a rigid material. If therigid material is bent, such as when tracking into the aortic arch, therigid material tends to kink, making it difficult if not impossible todeploy the stent graft.

Common features of vascular prosthesis delivery systems include atapered nose cone fixedly connected to a guidewire lumen, which has aninner diameter substantially corresponding to an outer diameter of theguidewire such that the guidewire lumen slides easily over and along theguidewire. A removable, hollow catheter covers and holds a compressedprosthesis in its hollow and the catheter is fixedly connected to theguidewire lumen. Thus, when the prosthesis is in a correct position forimplantation, the physician withdraws the hollow catheter to graduallyexpose the self-expanding prosthesis from its proximal end towards itsdistal end. When the catheter has withdrawn a sufficient distance fromeach portion of the expanding framework of the prosthesis, the frameworkcan expand to its native position, preferably, a position that has adiameter at least as great as the inner diameter of the vessel wall to,thereby, tightly affix the prosthesis in the vessel. When the catheteris entirely withdrawn from the prosthesis and, thereby, allows theprosthesis to expand to the diameter of the vessel, the prosthesis isfully expanded and connected endoluminally to the vessel along theentire extent of the prosthesis, e.g., to treat a dissection. Whentreating an aneurysm, for example, the prosthesis is in contact with thevessel's proximal and distal landing zones when completely released fromthe catheter. At such a point in the delivery, the delivery system canbe withdrawn from the patient. The prosthesis, however, cannot bereloaded in the catheter if implantation is not optimal.

The aorta usually has a relatively straight portion in the abdominalregion and in a lower part of the thoracic region. However, in the upperpart of the thoracic region, the aorta is curved substantially,traversing an upside-down U-shape from the back of the heart over to thefront of the heart. As explained above, prior art delivery systems arerelatively hard and inflexible (the guidewire/catheter portion of theprior art delivery systems). Therefore, if the guidewire/catheter musttraverse the curved portion of the aorta, it will kink as it is curvedor it will press against the top portion of the aortic curve, possiblypuncturing the aorta if the diseased portion is located where theguidewire/catheter is exerting its force. Such a situation must beavoided at all costs because the likelihood of patient mortality ishigh. The prior art does not provide any way for substantially reducingthe stress on the curved portion of the aorta or for making theguidewire/catheter sufficiently flexible to traverse the curved portionwithout causing damage to the vessel.

The present invention, however, provides significant features not foundin the prior art that assist in placing a stent graft in a curvedportion of the aorta in a way that substantially reduces the stress onthe curved portion of the aorta and substantially reduces the insertionforces needed to have the compressed graft traverse the curved portionof the aorta. As set forth above, the longitudinal support member 40 ispre-formed in a desired spiral/helical shape before being attached tothe graft sleeve 10 and, in a preferred embodiment, is curved in apatient-customized way to accommodate the anticipated curve of theactual vessel in which the graft will be implanted. As such, optimalpositioning of the stent graft 1 occurs when the longitudinal supportmember 40 is placed substantially at the superior longitudinal surfaceline of the curved aorta (with respect to anatomical position). Suchplacement can be effected in two ways. First, the stent graft 1, thesupport member 40, or any portion of the delivery system that is nearthe target site can be provided with radiopaque markers that aremonitored by the physician and used to manually align the support member40 in what is perceived as an optimal position. The success of thisalignment technique, however, is dependent upon the skill of thephysician. Second, the delivery system can be made to automaticallyalign the support member 40 at the optimal position. No such systemexisted in the prior art. However, the delivery system of the presentinvention provides such an alignment device, thereby, eliminating theneed for physician guesswork as to the three-dimensional rotationalposition of the implanted stent graft 1. This alignment device isexplained in further detail below with respect to FIGS. 64 to 67.

The delivery system of the present invention also has a very simple touse handle assembly. The handle assembly takes advantage of the factthat the inside diameter of the aorta is substantially larger that theinside diameter of the femoral arteries. The present invention,accordingly, uses a two-stage approach in which, after the device isinserted in through the femoral artery and tracks up into the abdominalarea of the aorta (having a larger diameter (see FIG. 19) than thefemoral artery), a second stage is deployed (see FIG. 20) allowing asmall amount of expansion of the stent graft while still constrained ina sheath; but this sheath, made of fabric/woven polymer or similarflexible material, is very flexible. Such a configuration gives thedelivery system greater flexibility for tracking, reduces deploymentforces because of the larger sheath diameter, and easily overcome kinksbecause the sheath is made of fabric.

To describe the delivery system of the present invention, the method foroperating the delivery assembly 600 will be described first inassociation with FIGS. 10, 11, and 12. Thereafter, the individualcomponents will be described to allow a better understanding of how eachstep in the process is effected for delivering the stent graft 1 to anyportion of the aorta 700 (see FIGS. 19 to 24), in particular, the curvedportion 710 of the aorta.

Initially, the distal end 14 of the stent graft 1 is compressed andplaced into a hollow, cup-shaped, or tubular-shaped graft holdingdevice, in particular, the distal sleeve 644 (see, e.g., FIG. 25). Atthis point, it is noted that the convention for indicating directionwith respect to delivery systems is opposite that of the convention forindicating direction with respect to stent grafts. Therefore, theproximal direction of the delivery system is that portion closest to theuser/physician employing the system and the distal direction correspondsto the portion farthest away from the user/physician, i.e., towards thedistal-most nose cone 632.

The distal sleeve 644 is fixedly connected to the distal end of thegraft push lumen 642, which lumen 642 provides an end face for thedistal end 14 of the stent graft 1. Alternatively, the distal sleeve 644can be removed entirely. In such a configuration, as shown in FIG. 12,for example, the proximal taper of the inner sheath 652 can provide themeasures for longitudinally holding the compressed distal end of thegraft 1. If the sleeve 644 is removed, it is important to prevent thedistal end 14 of the stent graft 1 from entering the space between theinterior surface of the hollow sheath lumen 654 and the exterior surfaceof the graft push lumen 642 slidably disposed in the sheath lumen 654.Selecting a radial thickness of the space to be less than the diameterof the wire making up the stent 20, 30 (in particular, no greater thanhalf a diameter thereof) insures reliable movement of the distal end 14of the stent graft 1. In another alternative configuration shown in FIG.68, the distal sleeve 644 can be a disk-shaped buttress 644 present atthe distal end of the graft push lumen 642. An example configuration canprovide the buttress 644 with a hollow proximal insertion peg 6442, ahollow distal stiffening tube 6444, and an intermediate buttress wall6446. The buttress 644 is concentric to the center axis of the deliverysystem 600 and allows the co-axial guidewire lumen 620 and apex releaselumen 640 to pass therethrough. The peg 6442 allows for easy connectionto the graft push lumen 643. The stiffening tube 64 creates a transitionin stiffness from the graft push lumen 642 to the apex release lumen 620and guidewire lumen 640 and provides support to the lumen 620, 640located therein. Such a transition in stiffness reduces any possibilityof kinking at the distal end of the graft push lumen 642 and aids intransferring force from the graft push lumen 642 to the lumen therein620, 640 when all are in a curved orientation. The buttress wall 6446provides a flat surface that will contact the distal-end-facing side ofthe stent graft 1 and can be used to push the stent graft distally whenthe graft push lumen 642 is moved distally. The alternativeconfiguration of the buttress 644 insures that the stent graft 1 doesnot become impinged within the graft push lumen 642 and the lumentherein 620, 640 when these components are moved relative to each other.

As set forth in more detail below, each apex 32 of the bare stent 30 is,then, loaded into the apex capture device 634 so that the stent graft 1is held at both its proximal and distal ends. The loaded distal end 14,along with the distal sleeve 644 and the graft push lumen 642, are, inturn, loaded into the inner sheath 652, thus, further compressing theentirety of the stent graft 1. The captured bare stent 30, along withthe nose cone assembly 630 (including the apex capture device 634), isloaded until the proximal end of the nose cone 632 rests on the distalend of the inner sheath 652. The entire nose cone assembly 630 andsheath assembly 650 is, then, loaded proximally into the rigid outercatheter 660, further compressing the stent graft 1 (resting inside theinner sheath 652) to its fully compressed position for later insertioninto a patient. See FIG. 63.

The stent graft 1 is, therefore, held both at its proximal and distalends and, thereby, is both pushed and pulled when moving from a firstposition (shown in FIG. 19 and described below) to a second position(shown in FIG. 21 and described below). Specifically, pushing isaccomplished by the non-illustrated interior end face of the hollowdistal sleeve 644 (or the taper 653 of the inner sheath 652) and pullingis accomplished by the hold that the apex capture device 634 has on theapices 32 of the bare stent 30.

The assembly 600 according to the present invention tracks along aguidewire 610 already inserted in the patient and extending through theaorta and up to, but not into, the left ventricle of the heart 720.Therefore, a guidewire 610 is inserted through the guidewire lumen 620starting from the nose cone assembly 630, through the sheath assembly650, through the handle assembly 670, and through the apex releaseassembly 690. The guidewire 610 extends out the proximal-most end of theassembly 600. The guidewire lumen 620 is coaxial with the nose coneassembly 630, the sheath assembly 650, the handle assembly 670, and theapex release assembly 690 and is the innermost lumen of the assembly 600immediately surrounding the guidewire 610.

Before using the delivery system assembly 600, all air must be purgedfrom inside the assembly 600. Therefore, a liquid, such as sterileU.S.P. saline, is injected through a non-illustrated tapered luerfitting to flush the guidewire lumen at a non-illustrated purge portlocated near a proximal end of the guidewire lumen. Second, saline isalso injected through the luer fitting 612 of the lateral purge-port(see FIG. 11), which liquid fills the entire internal co-axial space ofthe delivery system assembly 600. It may be necessary to manipulate thesystem to facilitate movement of the air to be purged to the highestpoint of the system.

After purging all air, the system can be threaded onto the guidewire andinserted into the patient. Because the outer catheter 660 has apredetermined length, the fixed front handle 672 can be disposedrelatively close to the entry port of the femoral artery. It is noted,however, that the length of the outer catheter 660 is sized such that itwill not have the fixed proximal handle 672 directly contact the entryport of the femoral artery in a patient who has the longest distancebetween the entry port and the thoracic/abdominal junction 742, 732 ofthe aorta expected in a patient (this distance is predetermined). Thus,the delivery assembly 600 of the present invention can be used withtypical anatomy of the patient. Of course, the assembly 600 can be sizedto any usable length.

The nose cone assembly 630 is inserted into a patient's femoral arteryand follows the guidewire 610 until the nose cone 632 reaches the firstposition at a level of the celiac axis. The first position is shown inFIG. 19. The nose cone assembly 630 is radiopaque, whether wholly orpartially, to enable the physician to determine fluoroscopically, forexample, that the nose cone assembly 630 is in the first position. Forexample, the nose cone 632 can have a radiopaque marker 631 anywherethereon or the nose cone 632 can be entirely radiopaque.

After the nose cone assembly 630 is in the first position shown in FIG.19, the locking ring 676 is placed from its neutral position N, shown inFIG. 10, into its advancement position A, shown in FIG. 11. As will bedescribed below, placing the locking ring 676 into its advancementposition A allows both the nose cone assembly 630 and the internalsheath assembly 650 to move as one when the proximal handle 678 is movedin either the proximal or distal directions because the locking ring 676radially locks the graft push lumen 642 to the lumens of the apexrelease assembly 690 (including the guidewire lumen 620 and an apexrelease lumen 640). The locking ring 676 is fixedly connected to asheath lumen 654.

Before describing how various embodiments of the handle assembly 670function, a summary of the multi-lumen connectivity relationships,throughout the neutral N, advancement A, and deployment D positions, isdescribed.

When the locking ring is in the neutral position N shown in FIG. 10, thepusher clasp spring 298 shown in FIG. 48 and the proximal spring 606shown in FIG. 52 are both disengaged. This allows free movement of thegraft push lumen 642 with the guidewire lumen 620 and the apex releaselumen 640 within the handle body 674.

When the locking ring 676 is moved into the advancement position A,shown in FIG. 11, the pusher clasp spring 298 shown in FIG. 48 isengaged and the proximal spring 606 shown in FIG. 52 is disengaged. Thesheath lumen 654 (fixedly attached to the inner sheath 652) is, thereby,locked to the graft push lumen 642 (fixedly attached to the distalsleeve 644) so that, when the proximal handle 678 is moved toward thedistal handle 672, both the sheath lumen 654 and the graft push lumen642 move as one. At this point, the graft push lumen 642 is also lockedto both the guidewire lumen 620 and the apex release lumen 640 (whichare locked to one another through the apex release assembly 690 as setforth in more detail below). Accordingly, as the proximal handle 678 ismoved to the second position, shown with dashed lines in FIG. 11, thesheath assembly 650 and the nose cone assembly 630 progress distally outof the outer catheter 660 as shown in FIGS. 20 and 21 and with dashedlines in FIG. 11.

At this point, the sheath lumen 654 needs to be withdrawn from the stentgraft 1 to, thereby, expose the stent graft 1 from its proximal end 12to its distal end 14 and, ultimately, entirely off of its distal end 14.Therefore, movement of the locking ring 676 into the deployment positionD will engage the proximal spring 606 shown in FIG. 52 and disengage thepusher clasp spring 298 shown in FIG. 48. Accordingly, the graft pushlumen 642 along with the guidewire lumen 620 and the apex release lumen640 are locked to the handle body 674 so as not to move with respect tothe handle body 674. The sheath lumen 654 is unlocked from the graftpush lumen 642. Movement of the distal handle 678 back to the thirdposition (proximally), therefore, pulls the sheath lumen 654 proximally,thus, proximally withdrawing the inner sheath 652 from the stent graft1.

At this point, the delivery assembly 600 only holds the bare stent 30 ofthe stent graft 1. Therefore, final release of the stent graft 1 occursby releasing the bare stent 30 from the nose cone assembly 630, which isaccomplished using the apex release assembly 690 as set forth below.

In order to explain how the locking and releasing of the lumen occur asset forth above, reference is made to FIGS. 33 to 62.

FIG. 33 is a cross-sectional view of the proximal handle 678 and thelocking ring 676. A pusher clasp rotator 292 is disposed between a claspsleeve 614 and the graft push lumen 642. A specific embodiment of thepusher clasp rotator 292 is illustrated in FIGS. 34 through 39. Alsodisposed between the clasp rotator 292 and the graft push lumen 642 is arotator body 294, which is directly adjacent the graft push lumen 642. Aspecific embodiment of the rotator body 294 is illustrated in FIGS. 40through 43. Disposed between the rotator body 294 and the sheath lumen654 is a pusher clasp body 296, which is fixedly connected to therotator body 294 and to the locking ring 676. A specific embodiment ofthe pusher clasp body 296 is illustrated in FIGS. 44 through 46. Apusher clasp spring 298 operatively connects the pusher clasp rotator292 to the rotator body 294 (and, thereby, the pusher clasp body 296).

An exploded view of these components is presented in FIG. 48, where anO-ring 293 is disposed between the rotator body 294 and the pusher claspbody 296. As shown in the plan view of FIG. 47, a crimp ring 295connects the sheath lumen 654 to the distal projection 297 of the pusherclasp body 296. A hollow handle body 674 (see FIGS. 10, 11, and 33), onwhich the proximal handle 678 and the locking ring 676 are slidablymounted, holds the pusher clasp rotator 292, the rotator body 294, thepusher clasp body 296, and the pusher clasp spring 298 therein. Thisentire assembly is rotationally mounted to the distal handle 672 forrotating the stent graft 1 into position (see FIGS. 23 and 24 and theexplanations thereof below). A specific embodiment of the handle body674 is illustrated in FIG. 49.

A setscrew 679 extends from the proximal handle 678 to contact alongitudinally helixed groove in the pusher clasp rotator 292 (shown inFIGS. 36 and 38). Thus, when moving the proximal handle 678 proximallyor distally, the pusher clasp rotator 292 rotates clockwise orcounter-clockwise.

An alternative embodiment of the locking ring 676 is shown in FIGS. 50et seq., which is the preferred embodiment because, instead of applyinga longitudinal movement to rotate the pusher clasp spring 298 throughthe cam/follower feature of the proximal handle 678 and pusher clasprotator 292, a rotating locking knob 582 is located at the proximal endof the handle body 674. The knob 582 has three positions that areclearly shown in FIG. 51: a neutral position N, an advancement positionA, and a deployment position D. The functions of these positions N, A, Dcorrespond to the positions N, A, D of the locking ring 676 and theproximal handle 678 as set forth above.

In the alternative embodiment, a setscrew 584 is threaded into the claspsleeve 614 through a slot 675 in the handle body 674 and through a slot583 in the knob 582 to engage the locking knob 582. Because of thex-axis orientation of the slot 583 in the knob 582 and the y-axisorientation of the slot 675 in the handle body 674, when the knob 582 isslid over the end of the handle body 674 and the setscrew 584 is screwedinto the clasp sleeve 614, the knob 582 is connected fixedly to thehandle body 674. When the locking knob 582 is, thereafter, rotatedbetween the neutral N, advancement A, and deployment D positions, theclasp sleeve 614 rotates to actuate the spring lock (see FIGS. 48 and52).

A setscrew 586, shown in FIG. 53, engages a groove 605 in the proximalclasp assembly 604 to connect the proximal clasp assembly 604 to theclasp sleeve 614 but allows the clasp sleeve 614 to rotate around theclasp body 602. The clasp sleeve 614 is shown in FIGS. 50 and 53 and, inparticular, in FIGS. 59 to 62. The proximal clasp assembly 604 of FIG.53 is more clearly shown in the exploded view of FIG. 52. The proximalclasp assembly 604 is made of the components including a proximal spring606, a locking washer 608, a fastener 603 (in particular, a screwfitting into internal threads of the proximal clasp body 602), and aproximal clasp body 602. The proximal clasp body 602 is shown, inparticular, in FIGS. 54 through 58. The proximal clasp assembly 604 isconnected fixedly to the handle body 674, preferably, with a screw 585shown in FIG. 50 and hidden from view in FIG. 51 under knob 582.

The handle body 674 has a position pin 592 for engaging in positionopenings at the distal end of the locking knob 582. The position pin 592can be a setscrew that only engages the handle body 674. When thelocking knob 582 is pulled slightly proximally, therefore, the knob canbe rotated clockwise or counter-clockwise to place the pin 592 into theposition openings corresponding to the advancement A, neutral N, anddeployment D positions.

As shown in FIG. 18, to begin deployment of the stent graft 1, theuser/physician grasps both the distal handle 672 and the proximal handle678 and slides the proximal handle 678 towards the distal handle 672 inthe direction indicated by arrow A. This movement, as shown in FIGS. 19to 21, causes the flexible inner sheath 652, holding the compressedstent graft 1 therein, to emerge progressively from inside the outercatheter 660. Such a process allows the stent graft 1, while constrainedby the inner sheath 652, to expand to a larger diameter shown in FIG.12, this diameter being substantially larger than the inner diameter ofthe outer catheter 660 but smaller than the inner diameter of the vesselin which it is to be inserted. Preferably, the outer catheter 660 ismade of a polymer (co-extrusions or teflons) and the inner sheath 652 ismade of a material, such as a fabric/woven polymer or other similarmaterial. Therefore, the inner sheath 652 is substantially more flexiblethan the outer catheter 660.

It is noted, at this point, that the inner sheath 652 contains a taper653 at its proximal end, distal to the sheath's 652 connection to thesheath lumen 654 (at which connection the inner sheath 652 has a similardiameter to the distal sleeve 644 and works in conjunction with thedistal sleeve 644 to capture the distal end 14 of the stent graft 1. Thetaper 653 provides a transition that substantially prevents any kinkingof the outer catheter 660 when the stent graft 1 is loaded into thedelivery assembly 600 (as in the position illustrated in FIGS. 10 and11) and, also, when the outer catheter 660 is navigating through thefemoral and iliac vessels. One specific embodiment of the sheath lumen654 has a length between approximately 30 and approximately 40 inches,in particular, 36 inches, an outer diameter of between approximately0.20 and approximately 0.25 inches, in particular 0.238 inches, and aninner diameter between approximately 0.18 and approximately 0.22 inches,in particular, 0.206 inches.

When the proximal handle 678 is moved towards its distal position, shownby the dashed lines in FIG. 11, the nose cone assembly 630 and thesheath assembly 650 move towards a second position where the sheathassembly 650 is entirely out of the outer catheter 660 as shown in FIGS.20 and 21. As can be seen most particularly in FIGS. 20 and 21, as thenose cone assembly 630 and the sheath assembly 650 are emerging out ofthe outer catheter 660, they are traversing the curved portion 710 ofthe descending aorta. The tracking is accomplished visually by viewingradiopaque markers on various portions of the delivery system and/or thestent graft 1 with fluoroscopic measures. Such markers will be describedin further detail below. The delivery system can be made visible, forexample, by the nose cone 630 being radiopaque or containing radiopaquematerials.

It is noted that if the harder outer catheter 660 was to have been movedthrough the curved portion 710 of the aorta 700, there is a great riskof puncturing the aorta 700, and, particularly, a diseased portion 744of the proximal descending aorta 710 because the outer catheter 660 isnot as flexible as the inner sheath 652. But, because the inner sheath652 is so flexible, the nose cone assembly 630 and the sheath assembly650 can be extended easily into the curved portion 710 of the aorta 700with much less force on the handle than previously needed with prior artsystems while, at the same time, imparting harmless forces to theintraluminal surface of the curved aorta 710 due to the flexibility ofthe inner sheath 652.

At the second position shown in FIG. 21, the user/physician, usingfluoroscopic tracking of radiopaque markers (e.g., marker 631) on anyportion of the nose cone or on the stent graft 1 and/or sheathassemblies 630, 650, for example, makes sure that the proximal end 112of the stent graft 1 is in the correct longitudinal position proximal tothe diseased portion 744 of the aorta 700. Because the entire insertedassembly 630, 650 in the aorta 700 is still rotationally connected tothe portion of the handle assembly 670 except for the distal handle 672(distal handle 672 is connected with the outer sheath 660 and rotatesindependently of the remainder of the handle assembly 670), thephysician can rotate the entire inserted assembly 630, 650 clockwise orcounterclockwise (indicated in FIG. 20 by arrow B) merely by rotatingthe proximal handle 678 in the desired direction. Such a feature isextremely advantageous because the non-rotation of the outer catheter660 while the inner sheath 652 is rotating eliminates stress on thefemoral and iliac arteries when the rotation of the inner sheath 652 isneeded and performed.

Accordingly, the stent graft 1 can be pre-aligned by the physician toplace the stent graft 1 in the optimal circumferential position. FIG. 23illustrates the longitudinal support member 40 not in the correctsuperior position and FIG. 24 illustrates the longitudinal supportmember 40 in the correct superior position. The optimal superior surfaceposition is, preferably, near the longest superior longitudinal linealong the circumference of the curved portion of the aorta as shown inFIGS. 23 and 24. As set forth above, when the longitudinal supportmember 40 extends along the superior longitudinal line of the curvedaorta, the longitudinal support member 40 substantially eliminates anypossibility of forming a kink in the inferior radial curve of the stentgraft 1 during use and also allows transmission of longitudinal forcesexerted along the inside lumen of the stent graft 1 to the entirelongitudinal extent of the stent graft 1, thereby allowing the entireouter surface of the stent graft 1 to resist longitudinal migration.Because of the predefined curvature of the support member 40, thesupport member 40 cannot align exactly and entirely along the superiorlongitudinal line of the curved aorta. Accordingly, an optimal superiorsurface position of the support member 40 places as much of the centralportion of the support member 40 (between the two ends 47 thereof) aspossible close to the superior longitudinal line of the curved aorta. Aparticularly desirable implantation position has the superiorlongitudinal line of the curved aorta intersecting the proximal half ofthe support member 40—the proximal half being defined as that portion ofthe support member 40 located between the centerline 45 and the proximalsupport member loop 47. However, for adequate implantation purposes, thecenterline 45 of the support member 40 can be as much as seventycircumferential degrees away from either side of the superiorlongitudinal line of the curved aorta. Adequate implantation can meanthat the stent graft 1 is at least approximately aligned. Whenimplantation occurs with the stent graft 1 being less than seventydegrees, for example, less than forty degrees, away from either side ofthe superior longitudinal line of the curved aorta, then it issubstantially aligned.

In prior art stent grafts and stent graft delivery systems, the stentgraft is, typically, provided with symmetrically-shaped radiopaquemarkers along one longitudinal line and at least one othersymmetrically-shaped radiopaque marker disposed along anotherlongitudinal line on the opposite side (one-hundred eighty degrees(180°)) of the stent graft. Thus, using two-dimensional fluoroscopictechniques, the only way to determine if the stent graft is in thecorrect rotational position is by having the user/physician rotate thestent graft in both directions until it is determined that the firstlongitudinal line is superior and the other longitudinal line isanterior. Such a procedure requires more work by the physician and is,therefore, undesirable.

According to a preferred embodiment of the invention illustrated inFIGS. 27 and 28, unique radiopaque markers 232, 234 are positioned onthe stent graft 1 to assist the user/physician in correctly positioningthe longitudinal support member 40 in the correct aortic superiorsurface position with only one directional rotation, which correspondsto the minimal rotation needed to place the stent graft 1 in therotationally correct position.

Specifically, the stent graft 1 is provided with a pair of symmetricallyshaped but diametrically opposed markers 232, 234 indicating to theuser/physician which direction the stent graft 1 needs to be rotated toalign the longitudinal support member 40 to the superior longitudinalline of the curved aorta (with respect to anatomical position).Preferably, the markers 232, 234 are placed at the proximate end 12 ofthe graft sleeve 10 on opposite sides (one-hundred eighty degrees(180°)) of the graft sleeve 10.

The angular position of the markers 232, 234 on the graft sleeve 10 isdetermined by the position of the longitudinal support member 40. In apreferred embodiment, the support member 40 is between the two markers232, 234. To explain such a position, if the marker 232 is at a 0 degreeposition on the graft sleeve 10 and the marker 234 is at a one-hundredeighty degree (180°) position, then the centerline 45 of the supportmember 40 is at a ninety degree position. However, an alternativeposition of the markers can place the marker 234 ninety degrees awayfrom the first degree 41 (see FIG. 1). Such a positioning is dependentsomewhat upon the way in which the implantation is to be viewed by theuser/physician and can be varied based on other factors. Thus, theposition can be rotated in any beneficial way.

Preferred ancillary equipment in endovascular placement of the stentgraft 1 is a fluoroscope with a high-resolution image intensifiermounted on a freely angled C-arm. The C-arm can be portable, ceiling, orpedestal mounted. It is important that the C-arm have a complete rangeof motion to achieve AP to lateral projections without moving thepatient or contaminating the sterile field. Capabilities of the C-armshould include: Digital Subtraction Angiography, High-resolutionAngiography, and Roadmapping.

For introduction of the delivery system into the groin access arteries,the patient is, first, placed in a sterile field in a supine position.To determine the exact target area for placement of the stent graft 1,the C-arm is rotated to project the patient image into a left anterioroblique projection, which opens the radial curve of the thoracic aorticarch for optimal visualization without superimposition of structures.The degree of patient rotation will vary, but is usually 40 to 50degrees. At this point, the C-arm is placed over the patient with thecentral ray of the fluoroscopic beam exactly perpendicular to the targetarea. Such placement allows for the markers 232, 234 to be positionedfor correct placement of the stent graft 1. Failure to have the centralray of the fluoroscopic beam perpendicular to the target area can resultin parallax, leading to visual distortion to the patient anatomy due tothe divergence of the fluoroscopic x-ray beam, with a resultantmisplacement of the stent graft 1. An angiogram is performed and theproposed stent graft landing zones are marked on the visual monitor.Once marked, neither the patient, the patient table, nor thefluoroscopic C-arm can be moved, otherwise, the reference markers becomeinvalid. The stent graft 1 is, then, placed at the marked landing zones.

In a preferred embodiment, the markers 232, 234 are hemispherical, inother words, they have the approximate shape of a “D”. This shape ischosen because it provides special, easy-to-read indicators thatinstantly direct the user/physician to the correct placement positionfor the longitudinal support member 40. FIG. 27, for example,illustrates a plan view of the markers 232, 234 when they are placed inthe upper-most superior longitudinal line of the curved aorta. Thecorrect position is indicated clearly because the two hemispheres havethe flat diameters aligned on top of or immediately adjacent to oneanother such that a substantially complete circle is formed by the twohemispherically rounded portions of the markers 232, 234. This positionis also indicated in the perspective view of FIG. 28.

Each of FIGS. 27 and 28 have been provided with examples where themarkers 232, 234 are not aligned and, therefore, the stent graft 1 isnot in the correct insertion position. For example, in FIG. 27, twomarkers 232′, 234′ indicate a misaligned counter-clockwise-rotated stentgraft 1 when viewed from the plane 236 at the right end of the stentgraft 1 of FIG. 23 looking toward the left end thereof and down the axis11. Thus, to align the markers 232′, 234′ in the most efficient waypossible (the shortest rotation), the user/physician sees that thedistance between the two flat diameters is closer than the distancebetween the highest points of the hemispherical curves. Therefore, it isknown that the two flat diameters must be joined together by rotatingthe stent graft 1 clockwise.

FIG. 28 has also been provided with two markers 232″, 234″ indicating amisaligned clockwise-rotated stent graft 1 when viewed from the plane236 at the right end of the stent graft 1 of FIG. 27 looking toward theleft end thereof and down the axis 11. Thus, to align the markers 232″,234″ in the most efficient way possible (the shortest rotation), theuser/physician sees that the distance between the highest points of thehemispherical curves is smaller than the distance between the two flatdiameters. Therefore, it is known that the two flat diameters must bejoined together by rotating the stent graft 1 in the direction that thehighest points of the hemispherical curves point; in other words, thestent graft 1 must be rotated counter-clockwise.

A significant advantage provided by the diametrically opposed symmetricmarkers 232, 234 is that they can be used for migration diagnosisthroughout the remaining life of a patient after the stent graft 1 hasbeen placed inside the patient's body. If fluoroscopic or radiographictechniques are used any time after the stent graft 1 is inserted in thepatient's body, and if the stent graft 1 is viewed from the same angleas it was viewed when placed therein, then the markers' 232, 234relative positions observed should give the examining individual a veryclear and instantaneous determination as to whether or not the stentgraft 1 has migrated in a rotational manner.

The hemispherical shape of the markers 232, 234 are only provided as anexample shape. The markers 232, 234 can be any shape that allows auser/physician to distinguish alignment and direction of rotation foralignment. For example, the markers 232, 234 can be triangular, inparticular, an isosceles triangle having the single side be visiblylonger or shorter than the two equal sides.

As set forth above, alignment to the optimal implantation position isdependent upon the skill of the physician(s) performing theimplantation. The present invention improves upon the embodiments havinglongitudinal and rotational radiopaque markers 232, 234 andsubstantially eliminates the need for rotational markers. Specifically,it is noted that the guidewire 610 travels through a curve through theaortic arch towards the heart 720. It is, therefore, desirable topre-shape the delivery system to match the aorta of the patient.

The guidewire lumen 620 is formed from a metal, preferably, stainlesssteel. Thus, the guidewire lumen 620 can be deformed plastically intoany given shape. In contrast, the apex release lumen 640 is formed froma polymer, which tends to retain its original shape and cannotplastically deform without an external force, e.g., the use of heat.Therefore, to effect the pre-shaping of the delivery assembly 600, theguidewire lumen 620, as shown in FIG. 64, is pre-shaped with a curve ata distal-most area 622 of the lumen 620. The pre-shape can bedetermined, for example, using the fluoroscopic pre-operative techniquesdescribed above, in which the guidewire lumen 620 can be customized tothe individual patient's aortic shape. Alternatively, the guidewirelumen 620 can be pre-shaped in a standard manner that is intended to fitan average patient. Another alternative is to provide a kit that can beused to pre-shape the guidewire lumen 620 in a way that is somewhattailored to the patient, for example, by providing a set of deliverysystems 600 or a set of different guidewire lumens 620 that havedifferent radii of curvature.

With the pre-curved guidewire lumen 620, when the nose cone 632 andinner sheath 652 exit the outer catheter 660 and begin to travel alongthe curved guidewire 610, the natural tendency of the pre-curvedguidewire lumen 620 will be to move in a way that will best align thetwo curves to one another (see FIGS. 20 and 21). The primary factorpreventing the guidewire lumen 620 from rotating itself to cause such analignment is the torque generated by rotating the guidewire lumen 620around the guidewire 610. The friction between the aorta and the devicealso resists rotational motion. The delivery system 600, however, isconfigured naturally to minimize such torque. As set forth above withrespect to FIGS. 15 to 17, the guidewire lumen 620 freely rotates withinthe apex release lumen 640 and is only connected to the apex releaselumen 640 at the proximal-most area of both lumen 620, 640. While theinner sheath 652 advances through the aortic arch, the two lumen 620,640 are rotationally connected only at the apex release assembly 690.This means that rotation of the guidewire lumen 620 about the guidewire610 and within the apex release lumen 640 occurs along the entire lengthof the guidewire lumen 620. Because the metallic guidewire lumen 620 isrelatively rotationally elastic along its length, rotation of thedistal-most portion (near the nose cone assembly 630) with respect tothe proximal-most portion (near the apex release assembly 690) requiresvery little force. In other words, the torque resisting rotation of thedistal-most portion to conform to the curve of the guidewire 610 isnegligible. Specifically, the torque is so low that the force resistingthe alignment of the guidewire lumen 620 to the guidewire 610 causeslittle, negligible, or no damage to the inside of the aorta, especiallyto a dissecting inner wall of a diseased aorta.

Due to the configuration of the delivery system 600 of the presentinvention, when the guidewire lumen 620 is extended from the outercatheter 660 (along with the apex release lumen 640, the stent graft 1,the inner sheath 652 as shown in FIGS. 20 and 21, for example), thepre-shape of the guidewire lumen 620 causes automatic and naturalrotation of the entire distal assembly—including the stent graft 1—alongits longitudinal axis. This means that the length and connectivity ofthe guidewire lumen 620, and the material from of which the guidewirelumen 620 is made, allow the entire distal assembly (1, 620, 630, 640,650) to naturally rotate and align the pre-curved guidewire lumen 620with the curve of the guidewire 610—this is true even if the guidewirelumen 620 is inserted into the aorta entirely opposite the curve of theaorta (one-hundred eighty degrees (180°)). In all circumstances, thecurved guidewire lumen 620 will cause rotation of the stent graft 1 intoan optimal implantation position, that is, aligning the desired portionof the support member 40 within ±70 degrees of the superior longitudinalline of the curved aorta. Further, the torque forces acting againstrotation of the guidewire lumen 620 will not be too high to cause damageto the aorta while carrying out the rotation.

The self-aligning feature of the invention begins with a strategicloading of the stent graft 1 in the inner sleeve 652. To describe theplacement of the supporting member 40 of the stent graft 1 relative tothe curve 622 of the guidewire lumen 620, an X-Y coordinate curve planeis defined and shown in FIG. 64. In particular, the guidewire lumen 620is curved and that curve 622 defines the curve plane 624.

To insure optimal implantation, when loading the stent graft 1 into theinner sheath 652, a desired point on the supporting member 40 betweenthe centerline 45 of the stent graft 1 and the proximal support memberloop 47 is aligned to intersect the curve plane 624. The preferred, butnot required, location of the desired point on the supporting member 40is located forty-five (45) degrees around the circumference of the stentgraft 1 shown in FIG. 1 beginning from the first degree 41 in line withthe proximal support member loop 47. When the stent graft 1 is loaded inthe preferred orientation, it is ready for insertion into the innersleeve 652. During the loading process, the stent graft 1 and theguidewire lumen 620 are held constant rotationally. After such loading,the inner sleeve 652 is retracted into the outer catheter 660 and thedelivery system 600 is ready for purging with saline and use with apatient.

FIGS. 65 to 67 illustrate self-alignment of the distal assembly 620,630, 640, 650 after it is pushed out from the distal end of the outercatheter 660 (see FIGS. 20 and 21). FIG. 65 shows an aorta 700 and thedistal assembly after it has traversed the iliac arteries 802 and entersthe descending thoracic portion 804 of the aorta. The nose cone assembly630 is positioned just before the aortic arch 806 and the stent graft 1is contained within the inner sheath 652. A reference line 820 is placedon the stent graft 1 at a longitudinal line of the stent graft 1 that isintended to align with the superior longitudinal line 808 (indicatedwith dashes) of the aortic arch 806. In FIG. 65, the reference line 820also lies on the curved plane 624 defined by the pre-curved guidewirelumen 620. As can be clearly seen from FIG. 65, the reference line 820is positioned almost on or on the inferior longitudinal line of thecurved aorta—thus, the stent graft 1 is one-hundred eighty degrees(180°) out of alignment. FIG. 66 shows the nose cone assembly 630 fullyin the aortic arch 806 and the inner sleeve 652 at the entrance of theaortic arch 806. With the self-aligning configuration of the pre-curvedguidewire lumen 620, movement of the distal assembly from the positionshown in FIG. 65 to the position shown in FIG. 66 causes a rotation ofthe reference line 820 almost ninety degrees (90°) clockwise (withrespect to a view looking upward within the descending aorta) towardsthe superior longitudinal line 808. In FIG. 67, the nose cone assembly630 has reached, approximately, the left subclavian artery 810.Rotational movement of the distal assembly is, now, complete, with thereference line 820 almost aligned with the superior longitudinal line808 of the aortic arch 806. From the views of FIGS. 65 to 67, also shownis the fact that the pre-curved guidewire lumen 620 has not caused anyportion of the inner sleeve 652 to push against the inner surface of theaortic arch 806 with force—force that might exacerbate an aorticdissection.

It is noted that the guidewire lumen 620 need not be rotationallyfixedly connected to the apex release lumen 640 when the apex releaseassembly 690 is in the locked position shown in FIGS. 15 and 16.Instead, a non-illustrated, freely rotatable coupling can be interposedanywhere along the guidewire lumen 620 (but, preferably, closer to theapex release assembly 690). This coupling would have a proximal portionrotationally fixedly connected to the to the apex release lumen 640 whenthe apex release assembly 690 is in the locked position shown in FIGS.15 and 16 and a freely-rotatable distal portion that is fixedlyconnected to all of the guidewire lumen 620 disposed distal thereto.Thus, the guidewire lumen 620 near the sheath assembly 650 will alwaysbe freely rotatable and, thereby, allow easy and torque-free rotation ofthe guidewire lumen 620 about the guidewire 610.

It is also noted that the pre-curved section 622 of the guidewire lumenneed not be made at the manufacturer. As shown in FIG. 69, a curvingdevice can be provided with the delivery system 600 to allow thephysician performing the implantation procedure to tailor-fit the curve622 to the actual curve of the vessel in which the stent graft 1 is tobe implanted. Because different patients can have different aortic archcurves, a plurality of these curving devices can be provided with thedelivery system 600, each of the curving devices having a differentcurved shape. Each device can also have two sides with each side havinga different curved shape, thus, reducing the number of devices if alarge number of curves are required. Further, the curving devices canall be rotationally connected on a common axle or spindle for each oftransport, storage, and use.

For tailoring the curve to the patient's curved vessel, the physiciancan, for example, fluoroscopically view the vessel (e.g., aortic arch)and determine therefrom the needed curve by, for example, holding up thecurving device to the display. Any kind of curving device can be used toimpart a bend to the guidewire lumen 620 when the guidewire lumen 620 isbent around the circumference.

Because of the predefined curvature of the support member 40, thesupport member 40 cannot align exactly and entirely along the superiorlongitudinal line of the curved aorta. Accordingly, an optimal superiorsurface position of the support member 40 places as much of the centralportion of the support member 40 (between the two ends 47 thereof) aspossible close to the superior longitudinal line 808 of the curvedaorta. A particularly desirable implantation position has the superiorlongitudinal line 808 of the curved aorta intersecting the proximal halfof the support member 40—the proximal half being defined as that portionof the support member 40 located between the centerline 45 and theproximal support member loop 47. However, for adequate implantationpurposes, the centerline 45 of the support member 40 can be as much asseventy circumferential degrees away from either side of the superiorlongitudinal line of the curved aorta.

When the stent graft 1 is in place both longitudinally andcircumferentially (FIG. 21), the stent graft 1 is ready to be removedfrom the inner sheath 652 and implanted in the vessel 700. Becauserelative movement of the stent graft 1 with respect to the vessel is nolonger desired, the inner sheath 652 needs to be retracted while thestent graft 1 remains in place, i.e., no longitudinal or circumferentialmovement. Such immovability of the stent graft 1 is insured by, first,the apex capture device 634 of the nose cone assembly 630 holding thefront of the stent graft 1 by its bare stent 30 (see FIGS. 13, 22, and23) and, second, by unlocking the locking ring 676/placing the lockingring/knob in the D position—which allows the sheath lumen 654 to moveindependently from the guidewire lumen 620, apex release lumen 640, andgraft push lumen 642. The apex capture device 634, as shown in FIGS. 13,14, 30 and 311 (and as will be described in more detail below), isholding each individual distal apex 32 of the bare stent 30 in a securemanner—both rotationally and longitudinally.

The nose cone assembly 630, along with the apex capture device 634, issecurely attached to the guidewire lumen 620 (and the apex release lumen640 at least until apex release occurs). The inner sheath 652 issecurely attached to a sheath lumen 654, which is coaxially disposedaround the guidewire lumen 620 and fixedly attached to the proximalhandle 678. The stent graft 1 is also supported at its distal end by thegraft push lumen 642 and the distal sleeve 644 or the taper 653 of theinner sheath 652. (The entire coaxial relationship of the various lumen610, 620, 640, 642, 654, and 660 is illustrated for exemplary purposesonly in FIG. 25, and a portion of which can also be seen in the explodedview of the handle assembly in FIG. 50) Therefore, when the proximalhandle 678 is moved proximally with the locking ring 676 in thedeployment position D, the sheath lumen 654 moves proximally as shown inFIGS. 13, 22, and 23, taking the sheath 652 proximally along with itwhile the guidewire lumen 620, the apex release lumen 640, the graftpush lumen 642, and the distal sleeve 644 remain substantiallymotionless and, therefore, the stent graft 1 remains both rotationallyand longitudinally steady.

The stent graft 1 is, now, ready to be finally affixed to the aorta 700.To perform the implantation, the bare stent 30 must be released from theapex capture device 634. As will be described in more detail below, theapex capture device 634 shown in FIGS. 13, 14, and 29 to 32, holds theproximal apices 32 of the bare stent 30 between the distal apex head 636and the proximal apex body 638. The distal apex head 636 is fixedlyconnected to the guidewire lumen 620. The proximal apex body 638,however, is fixedly connected to the apex release lumen 640, which iscoaxial with both the guidewire lumen 620 and the sheath lumen 654 anddisposed therebetween, as illustrated diagrammatically in FIG. 25. (Aswill be described in more detail below, the graft push lumen 642 is alsofixedly connected to the apex release lumen 640.) Therefore, relativemovement of the apex release lumen 640 and the guidewire lumen 620separates the distal apex head 636 and a proximal apex body 638 from oneanother.

To cause such relative movement, the apex release assembly 690 has, in apreferred embodiment, three parts, a distal release part 692, a proximalrelease part 694, and an intermediate part 696 (which is shown in theform of a clip in FIGS. 16 and 26). To insure that the distal apex head636 and the proximal apex body 638 always remain fixed with respect toone another until the bare stent 30 is ready to be released, theproximal release part 694 is formed with a distal surface 695, thedistal release part 692 is formed with a proximal surface 693, and theintermediate part 696 has proximal and distal surfaces corresponding tothe surfaces 695, 693 such that, when the intermediate part 696 isinserted removably between the distal surface 695 and the proximalsurface 693, the intermediate part 696 fastens the distal release part692 and the proximal release part 694 with respect to one another in aform-locking connection. A form-locking connection is one that connectstwo elements together due to the shape of the elements themselves, asopposed to a force-locking connection, which locks the elements togetherby force external to the elements. Specifically, as shown in FIG. 26,the clip 696 surrounds a distal plunger 699 of the proximal release part694 that is inserted slidably within a hollow 698 of the distal releasepart 692. The plunger 699 of the proximal release part 694 can slidewithin the hollow 698, but a stop 697 inside the hollow 698 prevents thedistal plunger 699 from withdrawing from the hollow 698 more than thelongitudinal span of the clip 696.

To allow relative movement between the distal apex head 636 and theproximal apex body 638, the intermediate part 696 is removed easily withone hand and, as shown from the position in FIG. 16 to the position inFIG. 17, the distal release part 692 and the proximal release part 694are moved axially towards one another (preferably, the former is movedtowards the latter). Such movement separates the distal apex head 636and the proximal apex body 638 as shown in FIG. 14. Accordingly, thedistal apices 32 of the bare stent 30 are free to expand to theirnatural position in which the bare stent 30 is released against thevessel 700.

Of course, the apex release assembly 690 can be formed with any kind ofconnector that moves the apex release lumen 640 and the guidewire lumen620 relative to one another. In a preferred alternative embodiment, forexample, the intermediate part 696 can be a selectable lever that isfixedly connected to either one of the distal release part 692 or theproximal release part 694 and has a length equal to the width of theclip 696 shown in FIG. 26. Thus, when engaged by pivoting the leverbetween the distal release part 692 and the proximal release part 694,for example, the parts 692, 694 cannot move with respect to one anotherand, when disengaged by pivoting the lever out from between the parts692, 694, the distal release part 692 and the proximal release part 694are free to move towards one another.

The apex capture device 634 is unique to the present invention in thatit incorporates features that allow the longitudinal forces subjected onthe stent graft 1 to be fully supported, through the bare stent 30, byboth the guidewire lumen 620 and apex release lumen 640. Support occursby providing the distal apex head 636 with a distal surface 639—whichsurface 639 supports the proximal apices 32 of the bare stent 30 (shownin the enlarged perspective view of the distal apex head 636 in FIG.29). When captured, each proximal apex 32 of the bare stent 30separately rests on a distal surface 639, as more clearly shown in FIGS.30 and 31. The proximal spokes of the distal apex head 636 slide withinthe fingers of the proximal apex body 638 as these parts moves towardsone another. A slight space, therefore, exists between the fingers andthe outer circumferential surfaces of the spokes. To insure that thebare stent 30 does not enter this space (which would prevent a properrelease of the bare stent 30 from the apex capture device 634, a radialthickness of the space must be less than the diameter of the wire makingup the bare stent 30. Preferably, the space is no greater than half adiameter of the wire.

Having the distal surface 639 be the load-bearing surface of theproximal apices 32 ensures expansion of each and every one of the distalapices 32 from the apex release assembly 690. The proximal surface 641of the distal apex head 636 (see FIG. 30) meets with the interiorsurfaces of the proximal apex body 638 to help carry the apex loadbecause the apices of the bare stent 30 are captured therebetween whenthe apex capture device 634 is closed. Complete capture of the barestent 30, therefore, fully transmits any longitudinal forces acting onthe bare stent 30 to both the guidewire lumen 620 and apex release lumen640, making the assembly much stronger. Such capture can be clearly seenin the cut-away view of the proximal apex body 638 in FIG. 31. Forrelease of the apices 32 of the bare stent 30, the proximal apex body638 moves leftward with respect to FIGS. 30 to 33 (compare FIGS. 30 and31 with FIG. 32). Because friction exists between the apices 32 and the“teeth” of the proximal apex body 638 when the apices 32 are captured,the apices 32 will also try to move to the left along with the proximalapex body 638 and, if allowed to do so, possibly would never clear the“teeth” to allow each apex 32 to expand. However, as the proximal apexbody 638 disengages (moves in the direction of arrow C in FIG. 31),direct contact with the distal surface 639 entirely prevents the apices32 from sliding in the direction of arrow C along with the proximal apexbody 638 to ensure automatic release of every captured apex 32 of thebare stent 30. Because the proximal apex body 638 continues to move inthe direction of arrow C, eventually the “teeth” will clear theirrespective capture of the apices 32 and the bare stent 30 will expandentirely. The release position of the distal apex head 636 and theproximal apex body 638 is shown in FIGS. 14 and 32, and corresponds tothe position of the apex release assembly 690 in FIG. 17. As can beseen, tapers on the distal outer surfaces of the proximal apex body 638further assist in the prevention of catching the proximal apices 32 ofthe bare stent 30 on any part of the apex capture device 634. In thisconfiguration, the distal surfaces 639 bear all the load upon the barestent 30 and the fingers of the proximal apex body 638.

Simply put, the apex capture device 634 provides support for load placedon the stent graft 1 during advancement A of the inner sheath 652 andduring withdrawal of the inner sheath 652 (i.e., during deployment D).Such a configuration benefits the apposition of the bare stent 30 byreleasing the bare stent 30 after the entire graft sleeve 10 has beendeployed, thus reducing the potential for vessel perforation at thepoint of initial deployment.

When the stent graft 1 is entirely free from the inner sheath 652 asshown in FIG. 24, the proximal handle 678 is, then, substantially at ornear the third position (deployment position) shown in FIG. 10.

The stent graft 1 is, now, securely placed within the vessel 700 and theentire portion 630, 650, 660 of the assembly 600 may be removed from thepatient.

While the preferred embodiments of the invention have been illustratedand described, it will be clear that the invention is not so limited.Numerous modifications, changes, variations, substitutions, andequivalents will occur to those skilled in the art without departingfrom the spirit and scope of the present invention as defined by theappended claims.

1. A method of implanting a prosthesis in a patient at a treatment site,which comprises: providing a prosthesis delivery sheath with analignment device; loading a prosthesis into the sheath; advancing thesheath in a patient up to the treatment site; and viewing at least oneof a rotational and an axial position of the alignment device at thetreatment site and, if the sheath is not in a desired position, movingthe sheath to the desired position based upon the position of thealignment device.
 2. The method according to claim 1, which furthercomprises retracting the sheath to at least partially implant theprosthesis at the treatment site.
 3. The method according to claim 2,which further comprises carrying out the loading step by partiallycompressing the prosthesis in the sheath.
 4. The method according toclaim 3, which further comprises: providing the prosthesis deliverysheath as an inner sheath; slidably disposing the inner sheath in anouter sheath to further compress the prosthesis while the inner sheathis within the outer sheath; advancing the outer sheath containing theinner sheath in a patient towards the treatment site up to a givenposition at a distance from the treatment site; and while retaining theouter sheath in the given position, advancing the inner sheath out fromthe outer sheath to the treatment site to permit expansion of theprosthesis to the partially compressed state.
 5. The method according toclaim 4, which further comprises retracting the inner sheath to at leastpartially implant the prosthesis at the treatment site.
 6. The methodaccording to claim 5, which further comprises, upon completion ofprosthesis implantation, retracting both of the inner and outer sheathsfrom the patient.
 7. The method according to claim 4, which furthercomprises providing the inner sheath as a relatively flexible innersheath and the outer sheath as a relatively stiff outer sheath.
 8. Themethod according to claim 4, which further comprises carrying out theadvancing step by advancing the outer sheath towards the treatment siteonly up to a point at a distance from the treatment site greater than alongitudinal length of the prosthesis.
 9. The method according to claim4, which further comprises carrying out the advancing step by advancingthe outer sheath in vasculature of a patient towards a vasculartreatment site.
 10. The method according to claim 9, which furthercomprises carrying out the advancing step by advancing the outer sheathin aortic vasculature of the patient no closer to the heart than aceliac axis of the patient.
 11. The method according to claim 4, whichfurther comprises providing the outer sheath with a length sufficient toreach only up to a celiac axis of a patient.
 12. The method according toclaim 6, which further comprises carrying out the inner and outer sheathretracting step by: retracting the inner sheath into the outer sheath;and subsequently retracting the outer sheath containing the inner sheathfrom the patient.
 13. The method according to claim 4, which furthercomprises providing the inner sheath with a prosthesis holding innerdiameter at least as great as an inner diameter of the outer sheath. 14.The method according to claim 1, which further comprises providing thealignment device as a pair of radiopaque markers each having a contactdiameter and being symmetrical about the contact diameter on opposingsides of the contact diameter.
 15. The method according to claim 14,which further comprises connecting the markers at opposing sides of thesheath.
 16. The method according to claim 14, which further comprises:providing the sheath as a tubular sheath having a proximate end; andplacing the markers at the proximate end on opposite sides thereof. 17.The method according to claim 14, which further comprises providing themarkers in a hemispherical shape.
 18. The method according to claim 17,which further comprises placing the markers on opposite sides of thesheath along respective longitudinal axes of the sheath, opposition ofthe hemispherical markers forming a complete circular shape when themarkers are viewed from an orientation aligning the axes with oneanother.
 19. The method according to claim 14, wherein the markers areeach D-shaped.
 20. The method according to claim 19, which furthercomprises placing the markers on opposite sides of the sheath alongrespective longitudinal axes of the sheath, opposition of the D-shapedmarkers forming a complete ovular shape with the markers when themarkers are viewed from an orientation aligning the axes with oneanother.
 21. The method according to claim 1, which further comprisesproviding the alignment device as a pair of radiopaque markers eachhaving a first shape and being connected to opposing sides of thesheath, each of the first shapes including an alignment segment, and, ina plan view of one of the markers, the alignment segments aligning withone another to, together, define a second shape different from the firstshape.
 22. The method according to claim 21, wherein the second shape issymmetrical about the alignment segment.
 23. The method according toclaim 21, wherein the markers each have a shape selected from the groupconsisting of a hemisphere, a D-shape, a triangle, and an isoscelestriangle.
 24. The method according to claim 1, which further comprisesproviding the alignment device as a pair of symmetrically shaped anddiametrically opposed radiopaque markers connected to the sheath. 25.The method according to claim 1, which further comprises: providing thealignment device as a pair of radiopaque markers on opposing sides of alongitudinal axis of the sheath such that, when viewed from a side ofthe sheath, the markers together form a given shape; carrying out theadvancing step by advancing the sheath in a blood vessel while viewingthe alignment device; and aligning the sheath in a given orientation byrotating the sheath along the longitudinal axis until the viewed markerssubstantially form the given shape.
 26. The method according to claim25, which further comprises forming the markers each with a shape havinga contact segment, the shape being symmetrical, when the two contactsegments are aligned with one another, about the aligned contactsegments.
 27. The method according to claim 25, which further comprises:shaping each of the markers with an alignment segment; and aligning thealignment segments with one another to form the given shape when viewedin a plan view of one of the markers.
 28. The method according to claim25, which further comprises selecting the given shape to communicate toa user a direction in which the sheath needs to rotate minimally toalign the markers in the given shape.
 29. The method according to claim28, which further comprises: providing each of the markers with a shapeselected from the group consisting of a hemispherical shape, a D-shape,and a triangular shape; and indicating the direction for minimalrotation with two flat diameters of the shape and two highest points ofopposing curves of the shape.
 30. The method according to claim 25,wherein the given shape is one of a circle, a diamond, and an oval. 31.The method according to claim 25, which further comprises providing eachof the markers in a shape selected from at least one a group consistingof a hemisphere, a D-shape, a triangle, and an isosceles triangle.
 32. Amethod of implanting a prosthesis in a patient at a treatment site,which comprises: providing a prosthesis delivery sheath having analignment device; loading a prosthesis into the sheath; advancing thesheath in a patient up to the treatment site; and viewing the rotationalposition of the alignment device at the treatment site and, if thesheath is not in a rotationally desired position, rotating the sheath tothe desired position.
 33. The method according to claim 32, whichfurther comprises viewing the axial position of the alignment device atthe treatment site and, if the sheath is not in an axially desiredposition, one of extending and retracting the sheath to the desiredaxial position.
 34. The method according to claim 32, which furthercomprises: providing the alignment device as a pair of markers onopposing sides of a longitudinal axis of the sheath such that, whenviewed from a side of the sheath, the pair of markers together form agiven shape that communicates to a user a direction in which the sheathneeds to rotate minimally to align the markers and form the given shape;carrying out the advancing step by advancing the sheath while viewingthe alignment device; and aligning the sheath in a given orientation byrotating the sheath along the longitudinal axis until the viewed markerssubstantially form the given shape.
 35. A method of implanting aprosthesis in a patient at a treatment site, which comprises: providinga prosthesis delivery sheath having an alignment device; loading aprosthesis into the sheath; advancing the sheath in a patient up to thetreatment site; and viewing the axial position of the alignment deviceat the treatment site and, if the sheath is not in an axially desiredposition, one of extending and retracting the sheath to the desiredaxial position.
 36. The method according to claim 35, which furthercomprises viewing the rotational position of the alignment device at thetreatment site and, if the sheath is not in a rotationally desiredposition, rotating the sheath to the desired position.
 37. The methodaccording to claim 35, which further comprises: providing the alignmentdevice as a pair of markers on opposing sides of a longitudinal axis ofthe sheath such that, when viewed from a side of the sheath, the pair ofmarkers together form a given shape that communicates to a user adirection in which the sheath needs to rotate minimally to align themarkers and form the given shape; carrying out the advancing step byadvancing the sheath while viewing the alignment device; and aligningthe sheath in a given orientation by rotating the sheath along thelongitudinal axis until the viewed markers substantially form the givenshape.
 38. A method of implanting a prosthesis in a patient at atreatment site, which comprises: providing a prosthesis delivery systemwith a relatively flexible inner sheath and a relatively stiff outersheath; providing the inner sheath with an alignment device; loading aprosthesis inside the inner sheath; loading the inner sheath containingthe prosthesis within the outer sheath; advancing the outer sheath in apatient towards the treatment site up to a given position at a distancefrom the treatment site; while retaining the outer sheath in the givenposition: advancing the inner sheath out from the outer sheath to thetreatment site; viewing the axially position of the alignment device atthe treatment site and, if the inner sheath is not in an axially desiredposition, one of advancing and retracting the inner sheath to thedesired position; viewing the rotational position of the alignmentdevice at the treatment site and, if the inner sheath is not in arotationally desired position, rotating the inner sheath to the desiredposition; and retracting the inner sheath to at least partially implantthe prosthesis at the treatment site; and upon completion of prosthesisimplantation, retracting both of the inner and outer sheaths from thepatient.
 39. The method according to claim 38, which further comprises:carrying out the first advancing step by threading the inner and outersheaths onto a guidewire and into a patient to place the outer sheathinto an aorta of the patient only up to a point at a distance from thetreatment site greater than a length of the prosthesis; and carrying outthe second advancing step by advancing the inner sheath distally out ofthe outer catheter in the aorta towards the patient's heart to transportthe prosthesis further upstream into the aorta.
 40. The method accordingto claim 39, which further comprises carrying out the advancing step byadvancing the inner sheath distally out of the outer sheath and into acurved thoracic aorta.
 41. The method according to claim 38, whichfurther comprises: providing the alignment device as a pair of markerson opposing sides of a longitudinal axis of the inner sheath such that,when viewed from a side of the inner sheath, the pair of markerstogether form a given shape that communicates to a user a direction inwhich the inner sheath needs to rotate minimally to align the markersand form the given shape; carrying out the inner sheath advancing stepby advancing the inner sheath while viewing the alignment device; andcarrying out the inner sheath rotating step by viewing the rotationalposition of the alignment device at the treatment site and, if the innersheath is not in a rotationally desired position, rotating the innersheath along the longitudinal axis until the viewed markerssubstantially form the given shape.